Authorized Representative 🇩🇪 Germany Active

PENTAX Europe GmbH

SRN: DE-AR-000000006 · Julius-Vosseler-Straße 104, 22527 Hamburg, Germany
Manufacturers
4
Devices
142
Certificates
3
PRRCs
3

Basic Information

Address
Julius-Vosseler-Straße 104, 22527 Hamburg, Germany
VAT Number
DE118587668
Trade Register
HRB 20 285

Non-EU Manufacturers

Name
PENTAX of America Inc.
PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC
PENTAX-Aohua Medical Technologies Co., Ltd.
HOYA Corporation

Manufacturers

Certificates

Type Number
MDD Annex V G2S 068357 0029
MDD Annex II (excluding section 4) G1 068357 0028
MDD Annex V G2S 068357 0029

Devices

C2 CryoBalloon™ Ablation System Nitroclip

Device
EU MDR · Eu Md Class 1 ·PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC·On the market·2 countries

C2 CryoBalloon(TM) System Controller

Device
EU MDR · Eu Md Class 2a ·PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC·On the market·2 countries

C2 Cryoablation(TM) System catheter

Device
EU MDR · Eu Md Class 2a ·PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC·On the market·2 countries

C2 Cryoablation(TM) System catheter

Device
EU MDR · Eu Md Class 2a ·PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC·On the market·2 countries

C2 Cryoablation(TM) System catheter

Device
EU MDR · Eu Md Class 2a ·PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC·On the market·2 countries

C2 Cryoablation(TM) System catheter

Device
EU MDR · Eu Md Class 2a ·PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC·On the market·2 countries

C2 Cryoablation(TM) System catheter

Device
EU MDR · Eu Md Class 2a ·PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC·On the market·2 countries

C2 Cryoablation(TM) System catheter

Device
EU MDR · Eu Md Class 2a ·PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC·On the market·2 countries

C2 CryoBalloon™Ablation system Catheter

Device
EU MDR · Eu Md Class 2a ·PENTAX MEDICAL A DIVISION OF PENTAX OF AMERICA INC·On the market·2 countries

Nasometer

Device
EU MDR · Eu Md Class 1 ·PENTAX of America Inc.·On the market

PENTAX Medical Ultrasound Upper G.I. Video Scope EG36-J10UR

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Ultrasound Upper G.I. Video Scope EG34-J10U

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical R/L Assistant Knob OE-B17

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Gas/Water Feeding Valve OE-B14

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Upper GI Scope EG27-i20c

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Upper GI Scope EG29-i20c

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i10cF2

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i10cM

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i10cF

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i10cL

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i20cWM

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i20cWF

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i20cWL

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i10cM

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i10cF

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i10cL

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i20cM

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i20cF

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i20cL

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i10NL+

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i10NF+

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i20cM

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i20cF

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC38-i20cL

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Single Use Balloon OE-A60

Device
EU MDD · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Balloon OE-A56

Device
EU MDD · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Balloon OE-A52

Device
EU MDD · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A65

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical VIDEO PROCESSOR EPK-i5000

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Balloon OE-A51

Device
EU MDD · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX WATER BOTTLE OS-H5 [EN]

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

A/W, Suction Channel Cleaning Adapter OF-B153

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Water Jet Channel Cleaning Adapter OE-C31

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Cylinder Cleaning Adapter OE-B16

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

WATER BOTTLE CLEANING ADAPTER OS-A63

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

AIR/WATER CHANNEL CLEANING & DISINFECTION ADAPTERS OF-G17

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Cleaning Adapter OF-B212

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Channel Cleaning Adapter OF-B162

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Channel Cleaning Adapter OF-B155

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Channel Cleaning Adapter OF-B166

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Channel Cleaning Adapter OF-B115

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Channel Cleaning Adapter OF-B75

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

SUCTION CHANNEL CLEANING & DISINFECTION ADAPTER OF-B103

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

SUCTION NIPPLE CLEANING ADAPTER OE-C8

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

AIR/WATER, SUCTION CHANNEL & DISINFECTION ADAPTER OE-C5

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Cleaning Adapter OE-G1

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

WATER JET CHANNEL CLEANING ADAPTER OE-C20

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Cleaning Adapter OE-B11

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Cleaning Adapter OE-B10

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Single Use Balloon OE-A61

Device
EU MDD · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Cleaning Brush CS6021T

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Cleaning Brush CS6030SN

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Cleaning Brush CS6002SN

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Cleaning Brush CS3025S

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Cleaning Brush CS3010S

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5522A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS-C13A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS-C12A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS-C11A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Cleaning Brush CS-C9S

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Cleaning Brush CS-C3S

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Cleaning Brush CS-C5S

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Cleaning Brush CS6021SN

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

Cleaning Brush CS6015ST

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5530A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5503A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS4010A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS3022A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS2037A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS2010A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS2022A

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Video Small Bowel Enteroscope VSB-2990i

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX ULTRASOUND UPPER G.I. VIDEOSCOPE EG-3270UK

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Esophagoscope EE17-J10

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX VIDEO DUODENOSCOPE ED34-i10T

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX VIDEO DUODENOSCOPE ED-3490TK

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Duodenoscope ED32-i10

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX VIDEO CYSTOSCOPE ECY-1575K

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Bronchoscope EB19-J10

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX VIDEO BRONCHOSCOPE EB-1990i

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX VIDEO BRONCHOSCOPE EB-1970TK

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Bronchoscope EB15-J10

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX VIDEO BRONCHOSCOPE EB-1170K

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Single Use Video Bronchoscope EB15-S01

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Single Use Video Bronchoscope EB11-S01

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX WATER BOTTLE OS-H4

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX CO2 Gas Feeding Adapter OF-G11

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Gas/Water Feeding Valve OF-B130

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Surgical Instrument Inlet Seal OF-B220

Device
EU MDD · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Irrigation Tap with Inlet Seal OF-B216

Device
EU MDD · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical PROfILE Single Use Endoscope Inlet seal OF-B215

Device
EU MDD · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Balloon/O-ring kit OF-A67

Device
EU MDD · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video PROCESSOR EPK-3000

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video PROCESSOR EPK-3000

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video PROCESSOR EPK-3000

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical VIDEO PROCESSOR EPK-i5000

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video PROCESSOR EPK-3000

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical VIDEO PROCESSOR EPK-i7010

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video PROCESSOR EPK-3000

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video PROCESSOR EPK-3000

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video PROCESSOR EPK-i5500c

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Snare DO-D Series DO-D2622

Device
EU MDD · Eu Md Class 2b ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Bipolar Hot Hemostasis Forceps HS-D Series HS-D2622

Device
EU MDD · Eu Md Class 2b ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Bipolar Hot Hemostasis Forceps HS-D Series HS-D2618

Device
EU MDD · Eu Md Class 2b ·HOYA Corporation ·On the market·32 countries

PENTAX Electro-Surgical Knife DP-D2622

Device
EU MDD · Eu Md Class 2b ·HOYA Corporation ·On the market·32 countries

PENTAX Electro-Surgical Knife DP-D2518

Device
EU MDD · Eu Md Class 2b ·HOYA Corporation ·On the market·32 countries

PENTAXMedical Electro-Surgical Knife DN-D Series DN-D2722B

Device
EU MDD · Eu Md Class 2b ·HOYA Corporation ·On the market·32 countries

PENTAXMedical Electro-Surgical Knife DN-D Series DN-D2718B

Device
EU MDD · Eu Md Class 2b ·HOYA Corporation ·On the market·32 countries

Gas/Water Feeding Valve OF-B194

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i10cM

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Single Use Suction Control Valve OF-B205

Device
EU MDR · Eu Md Class 1 ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Duodenoscope ED34-i10cT2

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Duodenoscope ED34-i10cT

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Processor EPK-i8020c

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Bronchoscope EB11-J10

Device
EU MDR · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i10cM

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i10cL

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i10cF

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i10cL

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Colonoscope EC34-i10cF

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical single use suction control valve OF-B205

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical VIDEO PROCESSOR EPK-i7010

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Duodenoscope ED34-i10T2

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Medical Video Bronchoscope EB11-J10

Device
EU MDD · Eu Md Class 2a ·HOYA Corporation ·On the market·32 countries

PENTAX Snare DO-D Series DO-D2618

Device
EU MDD · Eu Md Class 2b ·HOYA Corporation ·On the market·32 countries