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PENTAX Medical Cleaning Adapter OE-B10
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6217001A046SModel See UDI-DI information for model names
Identity
- Trade Name
- PENTAX Medical Cleaning Adapter OE-B10 EUDAMEDPENTAX Medical FDA UDI
- Generic Name
- Endoscope flushing adaptor, reusable FDA UDI
- Device Name
- Channel Cleaning Adapter EUDAMEDPENTAX Medical Cleaning Adapter OE-B10 FDA UDI
- Model / Reference
- See UDI-DI information for model names EUDAMED6217001A046S EUDAMEDOE-B10 FDA UDI
- Description
- PENTAX Medical Cleaning Adapter OE-B10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333239399 EUDAMEDFDA UDI
- Basic UDI-DI
- 4961333010509YG EUDAMED
- Direct Marketing DI
- 04961333239399 EUDAMED
- 510(k) Number
- K200090 FDA UDI
- FDA Product Code
- ITX FDA UDIODG FDA UDI
- EMDN Code
- V0799 PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Endoscope flushing adaptor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PENTAX Medical Cleaning Adapter OE-B10 by HOYA Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4961333010509YG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- HOYA Corporation
- EUDAMED SRN
- JP-MF-000005227
- Authorised Representative
- PENTAX Europe GmbH DE-AR-000000006
Sources (2)
- EUDAMED e8511ce4-f476-4e7d-a1f7-78f505300e7e 61 fields · synced Jul 31, 2026
- FDA UDI cdafd4d2-1ce5-493c-b207-d972e8f71e6a 34 fields · synced May 29, 2026