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 – Red - Pentax® FDA UDI
- Model / Reference
- 16-0004 EUDAMEDFDA UDI
- Description
- Biopsy Valve Covers – Red - Pentax® FDA UDI
Identifiers
- Catalog Number
- 16-0002 FDA UDI
- Primary DI / UDI-DI
- 00690521011533 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Gastro-urological guidewire, single-use
NON-STERILE Biopsy Valve Covers by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 57438045-7eb7-41f4-833c-1b665c346e2c 61 fields · synced Jul 9, 2026
- FDA UDI 97f6ddaa-2cc0-44d2-aab0-0554d4d954af 36 fields · synced May 30, 2026