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Single-use Biopsy Forceps
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BFUW-1008Model BFUW-1008、BFUW-1011、BFTW-1808、BFTW-1811、BFUW-1808、BFUN-1811、BFTW-2311、BFUN-2311
Identity
- Trade Name
- Single-use Biopsy Forceps EUDAMEDFDA UDI
- Generic Name
- Flexible endoscopic biopsy forceps, single-use FDA UDI
- Device Name
- Single-use Biopsy Forceps EUDAMEDThe product is composed of a handle, a sliding handle, a flexible catheter and a head end, sterilized with ethylene oxide. This product is intended for biopsy of mucosal tissue and/or removal of foreign bodies under endoscope. FDA UDI
- Model / Reference
- BFUW-1008、BFUW-1011、BFTW-1808、BFTW-1811、BFUW-1808、BFUN-1811、BFTW-2311、BFUN-2311 EUDAMEDBFUW-1008 EUDAMEDFDA UDI
- Description
- The product is composed of a handle, a sliding handle, a flexible catheter and a head end, sterilized with ethylene oxide. This product is intended for biopsy of mucosal tissue and/or removal of foreign bodies under endoscope. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381251579 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125018A8R EUDAMED
- Direct Marketing DI
- 06971381251579 EUDAMED
- FDA Product Code
- HFB FDA UDIFCL FDA UDI
- EMDN Code
- U0903010101 COLD BIOPSY FORCEPS FOR UROGENITAL ENDOSCOPY, SINGLE-USE EUDAMED
- GMDN Term
- Flexible endoscopic biopsy forceps, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 884.4530 FDA UDI876.1075 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Single-use Biopsy Forceps by Scivita Medical Technology Co., Ltd. — Class IIa — 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 | 697138125018A8R | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED e08df014-b7ca-4cbc-87e6-f2f5453178a2 61 fields · synced Jul 29, 2026
- FDA UDI 1bc286ed-a5b6-47cb-89c3-acd1b96562db 34 fields · synced May 30, 2026