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 EUDAMED
- Model / Reference
- MD-B-BF2418 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970401810154 EUDAMEDFDA UDI
- Basic UDI-DI
- 697040181BFBNECoatEF 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
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Yes
Manufacturing Date
No
Category: Flexible endoscopic biopsy forceps, single-use
Single Use Biopsy Forceps by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Flexible endoscopic biopsy forceps, single-use.
- Disposable Biopsy Forceps — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class IIa
- Single Use Biopsy Forceps — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class I
- Disposable Endoscopic Biopsy Forceps — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- POWER-ENDO — Jiangsu Power-endo Medical Technology Co., Ltd · Class IIa
- Single-use Biopsy Forceps — Anrei Medical (HZ) CO., LTD. · Class IIa
- Disposable Biopsy Forceps — Jiangsu Ate Medical Technology Co., Ltd. · Class IIa
- Disposable Biopsy Forceps — Endoaccess GmbH · Class IIa
- Single-Use Biopsy Forceps — Micro-Tech (Nanjing) Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697040181BFBNECoatEF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000012417
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 1a4c6011-caff-4493-873a-763635017e40 61 fields · synced Jul 11, 2026
- FDA UDI 9792170f-dd36-4a15-b16d-1b63c335f989 32 fields · synced May 30, 2026