Identity
- Trade Name
- Sterile Disposable Biopsy Forceps EUDAMEDG-Flex FDA UDI
- Generic Name
- Flexible endoscopic biopsy forceps, single-use FDA UDI
- Device Name
- Sterile Disposable Biopsy Forceps EUDAMEDDisposable Biopsy Forceps FDA UDI
- Model / Reference
- U230C EUDAMEDFDA UDI
- Description
- Disposable Biopsy Forceps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05420051301638 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200513-TF14-BBF-SU-4Q EUDAMED
- FDA Product Code
- FCL FDA UDI
- EMDN Code
- G0308010101 GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE EUDAMED
- GMDN Term
- Flexible endoscopic biopsy forceps, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.1075 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
Yes
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
Yes
FDA UDI
Sterile Disposable Biopsy Forceps by G-Flex Flexible Instruments Europe — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: Disposable & Reusable Biopsy Forceps
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 | 54200513-TF14-BBF-SU-4Q | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- G-Flex Flexible Instruments Europe
- EUDAMED SRN
- BE-MF-000000623
Sources (2)
- EUDAMED aa643771-ba04-4d68-8a88-3e50dfa2a0f4 61 fields · synced Jun 19, 2026
- FDA UDI 977bc522-7d11-442c-9ed7-4b00c9d59e49 33 fields · synced May 30, 2026