Identity
- Trade Name
- NON-STERILE Biopsy Valve Covers FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- NON-STERILE Biopsy Valve Covers EUDAMEDBiopsy Valve Covers – Blue - Olympus® & Fujinon® FDA UDI
- Model / Reference
- 16-0002 EUDAMEDFDA UDI
- Description
- Biopsy Valve Covers – Blue - Olympus® & Fujinon® FDA UDI
Identifiers
- Catalog Number
- 16-0002 FDA UDI
- Primary DI / UDI-DI
- 00690521011526 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210VALVECOVER1000NW EUDAMED
- FDA Product Code
- FFY FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Endoscope working-channel valve, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NON-STERILE Biopsy Valve Covers by Batrik Medical Manufacturing Inc. — 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 | 6905210VALVECOVER1000NW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 0bca4e94-c439-4066-85f4-81ca9b4e2976 61 fields · synced Jun 19, 2026
- FDA UDI 37abfac3-b8e6-4fdc-9525-a8ea8e485df9 36 fields · synced May 29, 2026