FDA Registration
Active
🇲🇾 Malaysia
PENTAX MEDICAL (PENANG) SDN. BHD.
Reg #: 3014605202
·
FEI: 3014605202
·
Expires 2026
Products
12
Proprietary Names
208
Establishment Types
1
Classifications
12
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Registration Details
- Registration Name
- PENTAX MEDICAL (PENANG) SDN. BHD.
- Registration Number
- 3014605202
- FEI Number
- 3014605202
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plot 554, Lorong Perusahaan 4, Prai Free Trade Zone
- City
- Penang Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K202365
Owner / Operator
- Firm Name
- HOYA Corporation PENTAX Division
- Operator Number
- 8030235
- Address
- 3 Paragon Drive
- City
- Montvale
- State
- NJ
- Postal Code
- 07645
- Country
- US
- Correspondent
- Paresh Patel
US Agent
- Business Name
- HOYA CORPORATION PENTAX DIVISION
- Contact Name
- Paresh Patel
- Address
- 3 Paragon Drive
- City
- Montvale
- State
- NJ
- ZIP
- 07645
- Country
- US
- [email protected]
- Phone
- 201 5712300 ext. 2312
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Duodenoscope And Accessories, Flexible/Rigid | FDT | Class 2 | Gastroenterology, Urology | No | 2021-04-28 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2014-04-22 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2024-12-09 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2019-01-08 |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | Class 2 | Gastroenterology, Urology | No | 2019-01-08 |
| Endoscope, Accessories, Image Post-Processing For Color Enhancement | PEA | Class 2 | Gastroenterology, Urology | No | 2018-04-06 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2018-04-06 |
| Sigmoidoscope And Accessories, Flexible/Rigid | FAM | Class 2 | Gastroenterology, Urology | No | 2009-06-05 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2007-06-29 |
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | No | 2023-01-25 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2009-06-04 |
| Laryngoscope, Non-Rigid | CAL | Class 1 | Anesthesiology | No | 2007-06-29 |
Proprietary Names
STERILE DISPOSABLE ELEVATOR CAP FOR DEC (OE-A65)
DEC HD VIDEO DUODENOSCOPE (ED32-i10)
VIDEO COLONOSCOPE (EC-3890TLK)
VALVE, SUCTION (OF-B120)
VIDEO COLONOSCOPE (EC-3490LK)
VIDEO COLONOSCOPE (EC-2990LI)
TUBE,IRRIGATION FOR 30/40 SERIES (OF-B113)
VIDEO COLONOSCOPE (EC-3490TLI)
VIDEO COLONOCOPE - I10 STANDARD (EC38-I10L)
WATER JET CHECK VALVE ADAPTER REPLACES O (OE-C12)
O RING SET FOR OF-B188 (OF-B192)
HDVIDEO COLONOSCOPE (EC-3490LI)
VIDEO COLONOSCOPE (EC-3890LI)
VIDEO COLONOSCOPE - I10 SLIM (EC34-I10L)
VIDEO COLONOSCOPE (EC-3890LK)
A/W VALVE (OF-B188)
OE-C14 CHECK VALVE SET-10 PCS. USE WITH (OE-C15)
VIDEO COLONOSCOPE (EC-3890LZI)
PENTAX Distal Rubber Hood(OE-A59)
O-RING MODEL (OF-B182)
PENTAX VIDEO COLONOSCOPE (EC-3890LZi)
PENTAX Medical R/L Assistant Knob (OE-B17)
PENTAX Medical Video Upper GI Scope (EG27-i20c)
PENTAX Medical Video Colonoscope (EC34-i20cL)
ULTRASOUND VIDEO GASTROSCOPE (EG-3670URK)
ADVANCED DIGITAL ULTRASOUND SYSTEM (HV-PREIRUS)
OPTIVISTA HD VIDEO PROCESSOR(EPK-I7010)
ULTRASOUND VIDEO GASTROSCOPE (EG-3270UK)
HITACHI ARIETTA 70 ULTRASOUND SCANNER (EUS-ARIETTA 70)
LINEAR ULTRASOUND VIDEO GASTROSCOPE (EG-3870UTK)
VIDEO PROCESSOR (EPK-i5010)
TOOL, BALLON ATTACHMENT 2 PCS (OF-A37)
LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C (EG-3870UTK)
BALLOON/O-RING KIT FOR ULTRASOUND, 20 PCS (OF-A67)
SOAKING CAP FOR US CONNECTOR (OE-U1)
AIR/WATER/SUCTION METAL OPTIONAL (OF-B153)
VIDEO GASTROSCOPE (EG-1690K)
HD VIDEO GASTROSCOPE (EG-2990I)
VIDEO GASTROSCOPE (EG-3890TK)
CLEANING ADAPTER, AIR/WATER (OF-G17)
SUCTION CHANNEL SELECTOR FOR EC/EG 70 SE (OF-B161)
HD VIDEO GASTROSCOPE (EG-2790I)
VIDEO GASTROSCOPE (EG-2790K)
O-RING SET FOR OF-B177 SUCTION VALVE (OF-B127)
FWJ CLEANING ADAPTER OE-C20 (OE-C20)
SILICONE OIL (OF-Z11)
VIDEO GASTROSCOPE (EG-3490K)
VIDEO GASTROSCOPE (EG27-i10)
VIDEO GASTROSCOPE - (EG29-I10)
VIDEO GASTROSCOPE (EG-2490K)
VIDEO GASTROSCOPE (EG-2990K)
CAP, CONNECTOR, FOR WATER JET FOR 30/40 (OF-B118)
2CH CLEANING ADAPTER (OF-B162)
VIDEO GASTROSCOPE (EG-2990Zi)
VIDEO GASTROSCOPE (EG16-K10)
AIR/WATER FEEDING VALVE FOR ULTRASOUND (OF-B172)
O-RING SET FOR OF B171 (OF-B187)
ADAPTER, AIR/WATER/SUCTION CHANNEL (OE-C5)
RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C (EG-3670URK)
SUCTION VALVE FOR ULTRASOUND SCOPES (OF-B171)
O RING SET FOR OE-U1 (OS-A69)
O-RING SET FOR OF-B172 (OF-B191)
BALLOON FOR EG-3630UR, 20 PCS (OE-A51)
PENTAX Medical single use scope holder, SCH-G2
PENTAX Medical Scope stand, SS-1
PENTAX Medical Video upper GI scope, EG17-J10
VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL11-J10)
CLEANING ADAPTER FOR INLET (OF-B218)
LAMP FOR EPK-3000 (OL-X30)
CLEANING ADAPTER (OF-B212)
VIDEO PROCESSOR (EPK-3000)
CONDENSER EARTH CABLE (OL-Z4)
O RING SET (OF-B214)
WHITE BALANCE ADJUSTER (OS-A43H)
SOAKING CAP (OE-C9)
VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL8-J10)
RUBBER INLET SEAL SINGLE PIECE , STD (OF-B190)
VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL15-J10)
SINGLE USE SUCTION CONTROL VALVE (OF-B205)
ETO STERILIZATION VENTING CAP (OF-C5)
EPK-PROMO(EPK-3000 Campaign Discount)
KEYBOARD FOR EPK-3000 (OS-A94)
VIDEO SIGMOIDOSCOPE (ES-3870K)
O-RING SET FOR THE OF-B178 A/W VALVE (OF-B184)
AIR/WATER/SUCTION RUBBER CHANNEL CLEANING ADAPTER (OF-B166)
AIR/WATER FEEDING VALVE FOR 70K/80K SERIES (OF-B183)
SUCTION NIPPLE CLEANING ADAPTER (OE-C8)
SUCTION VALVE REPLACES OF-B157 70K/80K (OF-B177)
VIDEO LARYNGOSTROBOSCOPE (VNL-1590STi)
VIDEO LARYNGOSTROBOSCOPE (VLS-1590STI)
VIDEO LARYNGOSTROBOSCOPE (VLS-1070STK)
RIGID ENDOSCOPE, STERRAD (9109)
VIDEO LARYNGOSTROBOSCOPE (VLS-1190STK)
LARYNGEAL STROBE (9500)
Footswitch for 9500(9500FS)
Laryngeal Microphone for 9500(9500LX)
Lapel Microphone for 9500(9500MC)
VIDEO LARYNGOSTROBOSCOPE (VNL-1190STK)
VIDEO LARYNGOSTROBOSCOPE (VNL-1070STK)
VIDEO PROCESSOR (CP-1000)
VIDEO NASOPHARYNGOLARYNGOSCOPE (VNL9-CP)
Leakage test adapter (OE-B9)
BALLOON FOR EG-3270UK, 20 PIECES (OE-A56)
ELEVATOR WIRE CAP (OE-B3)
INJECTION ADAPTER (OE-B5)
LINEAR ULTRASOUND VIDEO GASTROSCOPE (EG-3270UK)
SINGLE USE DISTAL CAP - ED34-I10T (OE-A62)
C.A.P. HD DUODENOSCOPE US (ED34-I10T-US)
PENTAX Medical Video Esophagoscope (EE17-J10)
Yellow single use cleaning brush(CS5522A)
O Ring Set for A/W Valve(OF-B192)
Double head single-use cleaning brush(CS-C13A)
Ventilation Cap(OE-C21)
PENTAX Medical Cylinder Cleaning Adapter (OE-B16)
PENTAX Medical Suction control valve OE-B13
PENTAX Medical Video Processor EPK-i8020c
PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15
PENTAX Medical Video Upper GI Scope EG29- i20c
Pentax Video Colonoscope (EC38-i20cL)
PENTAX Medical Water Jet Channel Cleaning Adapter OE-C31
PENTAX Medical Keyboard EN OS-A115
PENTAX Medical Air/Water feeding Valve OE-B12
PENTAX White Balance Adjuster (OS-A43)
PENTAX Portable Bronchoscopes (FB-15RBS)
FIBEROPTIC BRONCHOSCOPE (FB-8V)
SUCTION VAL AUTO, CLAVABLE U/W EB,VB, FB (OF-B136)
FIBER OPTIC CABLE FOR BS-LH2 (BS-LC1)
FIBEROPTIC BRONCHOSCOPE (FB-15V)
BATTERY LIGHT SOURCE - LED (BS-LL1)
FIBEROPTIC BRONCHOSCOPE (FB-18V)
KIT,O-RING FOR OF-B76 6PCS (OF-B80)
CAP,SOAKING FOR PORTABLE BRONCHO BS-B1 (BS-B1)
SUCTION VALVE - RUBBER (OF-B53)
CAP ELVTR WIRE CLNG INLET (OF-B17)
RUBBER SUCTION VALVE (OF-B53)
EYEPIECE CAP (OF-D1)
Video Bronchoscope (EB15-J10)
Video Bronchoscope (EB19-J10)
O-RING KIT FOR OF-B95 SUCTION VALVE (OF-B100)
SUCTION VALVE AUTO CLAVABLE (OF-B140)
PENTAX Naso-Pharyngo-Laryngoscopes (FNL-15RP3)
PENTAX BALLOON PKG OF 20PCS (OE-A52)
ULTRASOUND VIDEO BRONCHOSCOPE (EB-1970UK)
BALLOON INSTALLATION DEVICE (OE-A53)
Cleaning Adapter (OE-B11)
ULTRASOUND VIDEO BRONCHOSCOPE (EB19-J10U)
Scanning Unit Connector Soaking Cap (OE-U4)
Single Use Balloon (OE-A61)
Junction Box to be used with Preirus Scanner (PUN-JBP1)
VIDEO NASO PHARYNGO LARYNGOSCOPE (VNL-1570STK)
SMALL BOWEL ENTEROSCOPE (VSB-3430K)
KIT, O-RING FOR OF-B33, B54, B77, B78 (OF-B35)
PENTAX Medical EG-J10U Endoscopic Ultrasound System (EUS-J10)
EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type)
EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type)
SINGLE USE BALLOON (OE-A60)
PENTAX Medical Cleaning Adapter(OE-G1)
PENTAX Medical O-Ring Set For EUS-J10 (OF-B219)
PENTAX Medical Suction/Balloon Suction Control Valve(OF-B206)
CLEANING ADAPTER FOR EG34-J10U (OE-B10)
PENTAX Medical Air/Water/balloon Feeding Valve(OF-B207)
FIBEROPTICINTUBATIONSCOPE (FI-13RBS)
CAP, EYEPIECE FOR RIGID PNTX OCLR (OF-D6)
FIBEROPTICINTUBATIONSCOPE (FI-7RBS)
FIBEROPTICINTUBATIONSCOPE (FI-9RBS)
FIBEROPTICINTUBATIONSCOPE (FI-10RBS)
FIBEROPTICINTUBATIONSCOPE (FI-16RBS)
IMAGINA COLONOSCOPE (EC34-i10CL)
IMAGINA VENTING CONNECTOR ADAPTER (OE-C29)
VIDEO GASTROSCOPE (EG29-i10C)
VIDEO PROCESSOR (EPK-i5500C)
IMAGINA COLONOSCOPE (EC38-i10CL)
PENTAX Medical keyboard EN (OS-A111)
PENTAX Medical Ventilation Cap(OE-C28)
PENTAX Medical keyboard EN (OS-A116)
STERILE DISPOSABLE ELEVATOR CAP FOR DEC (OE-a63)
DEC HD VIDEO DUODENOSCOPE (ED34-I10T2)
VIDEO ESOPHAGOSCOPE (EE-1580K)
RUBBER DISTAL TIP, SLIP ON FOR EG-2980K (OE-A41)
RUBBER INLET SEAL SINGLE PIECE, STD (OF-B173)
AIR CLEANING BRUSH ADAPTER (OF-B170)
WATER JET CHECK VALVE ADAPTER(OF-B119)
VIDEO BRONCHOSCOPE (EB-1990i)
SUCTION VALVE REPLACES OF-B154 70K SLIM (OF-B179)
VIDEO BRONCHOSCOPE (EB-1575K)
VIDEO BRONCHOSCOPE (EB-1975K)
VIDEO BRONCHOSCOPE (EB-1970K)
SUCTION CHANNEL CLEANING ADAPTER FOR EB (OF-B155)
VIDEO BRONCHOSCOPE (EB-1570K)
VIDEO BRONCHOSCOPE (EB-1170K)
O-RING SET FOR OF-B179 3 PCS (OF-B181)
VIDEO BRONCHOSCOPE (EB-1970TK)
FIBER NASO PHARYNGO LARYNGOSCOPE (FNL-7RP3)
FIBER NASO PHARYNGO LARYNGOSCOPE (FNL-10RP3)
PENTAX Portable Naso-Pharyngo-Laryngoscope (FNL-10RBS)
VIDEO GASTROSCOPE (EG34-i10)
Video Colonoscope (EC34-i10TL-US)
PENTAX Medical Video Colonoscopes (EC34-i10L)
PENTAX Medical Video Colonoscopes (EC38-i10L)
PENTAX Medical Video Upper GI Scopes (EG-3890TK)
PENTAX Medical Video Upper GI Scopes (EG29-i10)
PENTAX Medical Video Upper GI Scopes (EG27-i10)
PENTAX Medical Video Colonoscopes (EC-3890TLK)
PENTAX Medical Video Colonoscopes (EC-2990Li)
PENTAX Medical Video Upper GI Scopes (EG-2990i)
PENTAX Medical Video Colonoscopes (EC-3890Li)
PENTAX Medical Video Upper GI Scopes (EG-2490K)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device