BEUDAMED

EU Manufacturer 🇯🇵 Japan Active

HOYA Corporation

SRN: JP-MF-000005227 · Nishi-Shinjuku, Shinjuku-ku 6-10-1, 160-0023 Tokyo, Japan

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Basic UDI-DIs

Total Devices

132

On Market

132

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Nishi-Shinjuku, Shinjuku-ku 6-10-1, 160-0023 Tokyo, Japan
Email: [email protected]
Website: https://www.pentaxmedical.com/

Regulatory Overview

Regulation

Eu Mdd 62

Eu Mdr 12

Classification

Eu Md Class 2a 53

Eu Md Class 1 13

Eu Md Class 2b 8

Device Types

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Expiry Date
MDD Annex V	G2S 068357 0029	TÜV SÜD Product Service GmbH	May 26, 2024
MDD Annex II (excluding section 4)	G1 068357 0028	TÜV SÜD Product Service GmbH	May 26, 2024
MDD Annex V	G2S 068357 0029	TÜV SÜD Product Service GmbH	May 26, 2024

Market Presence

Devices from this manufacturer are available in 32 countries across Europe.

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

Device Portfolio

Name	Regulation	Classification	Market Status	Certificates
PENTAX Medical Single Use Balloon OE-A61	EU MDD	Eu Md Class 1	On Market	1
A/W, Suction Channel Cleaning Adapter OF-B153	EU MDR	Eu Md Class 1	On Market	0
AIR/WATER CHANNEL CLEANING & DISINFECTION ADAPTERS OF-G17	EU MDR	Eu Md Class 1	On Market	0
AIR/WATER, SUCTION CHANNEL & DISINFECTION ADAPTER OE-C5	EU MDR	Eu Md Class 1	On Market	0
Channel Cleaning Adapter OF-B115	EU MDR	Eu Md Class 1	On Market	0
Channel Cleaning Adapter OF-B155	EU MDR	Eu Md Class 1	On Market	0
Channel Cleaning Adapter OF-B162	EU MDR	Eu Md Class 1	On Market	0
Channel Cleaning Adapter OF-B166	EU MDR	Eu Md Class 1	On Market	0
Channel Cleaning Adapter OF-B75	EU MDR	Eu Md Class 1	On Market	0
Cleaning Brush CS-C3S	EU MDR	Eu Md Class 1	On Market	0
Cleaning Brush CS-C5S	EU MDR	Eu Md Class 1	On Market	0
Cleaning Brush CS-C9S	EU MDR	Eu Md Class 1	On Market	0
Cleaning Brush CS3010S	EU MDR	Eu Md Class 1	On Market	0
Cleaning Brush CS3025S	EU MDR	Eu Md Class 1	On Market	0
Cleaning Brush CS6002SN	EU MDR	Eu Md Class 1	On Market	0
Cleaning Brush CS6015ST	EU MDR	Eu Md Class 1	On Market	0
Cleaning Brush CS6021SN	EU MDR	Eu Md Class 1	On Market	0
Cleaning Brush CS6021T	EU MDR	Eu Md Class 1	On Market	0
Cleaning Brush CS6030SN	EU MDR	Eu Md Class 1	On Market	0
Gas/Water Feeding Valve OF-B194	EU MDD	Eu Md Class 2a	On Market	1
PENTAX Balloon OE-A51	EU MDD	Eu Md Class 1	On Market	1
PENTAX Balloon OE-A52	EU MDD	Eu Md Class 1	On Market	1
PENTAX Balloon OE-A56	EU MDD	Eu Md Class 1	On Market	1
PENTAX Balloon/O-ring kit OF-A67	EU MDD	Eu Md Class 1	On Market	1
PENTAX CO2 Gas Feeding Adapter OF-G11	EU MDD	Eu Md Class 2a	On Market	1
PENTAX Electro-Surgical Knife DP-D2518	EU MDD	Eu Md Class 2b	On Market	1
PENTAX Electro-Surgical Knife DP-D2622	EU MDD	Eu Md Class 2b	On Market	1
PENTAX Gas/Water Feeding Valve OF-B130	EU MDD	Eu Md Class 2a	On Market	1
PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical Bipolar Hot Hemostasis Forceps HS-D Series HS-D2618	EU MDD	Eu Md Class 2b	On Market	1
PENTAX Medical Bipolar Hot Hemostasis Forceps HS-D Series HS-D2622	EU MDD	Eu Md Class 2b	On Market	1
PENTAX Medical Cleaning Adapter OE-B10	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical Cleaning Adapter OE-B11	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical Cleaning Adapter OE-G1	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical Cleaning Adapter OF-B212	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical Cylinder Cleaning Adapter OE-B16	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical Gas/Water Feeding Valve OE-B14	EU MDR	Eu Md Class 2a	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS-C11A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS-C12A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS-C13A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS2010A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS2022A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS2037A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS3022A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS4010A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5503A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5522A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5530A	EU MDR	Eu Md Class 1	On Market	0
PENTAX Medical PROfILE Single Use Endoscope Inlet seal OF-B215	EU MDD	Eu Md Class 1	On Market	1
PENTAX Medical PROfILE Single Use Endoscope Irrigation Tap with Inlet Seal OF-B216	EU MDD	Eu Md Class 1	On Market	1

View all 132 devices →

PRRC

Name

Junichi Odaira

Country

🇯🇵 Japan

Authorized Representative

Name

PENTAX Europe GmbH

Country

🇩🇪 Germany

Importer

Name

PENTAX Europe GmbH

Country

🇩🇪 Germany

Notified Bodies

TÜV SÜD Product Service GmbH

3 certs

Competent Authority

Name

DE/CA05 - Behorde fur Justiz und Verbraucherschutz

Country

🇩🇪 Germany

More about this competent authority →

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