Disposable Swinging Biopsy Forceps
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, short-term FDA UDI
- Device Name
- Disposable Swinging Biopsy Forceps EUDAMED
- Model / Reference
- 5021 series~50216series EUDAMEDAG-5024-2323 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06959664910900 EUDAMEDFDA UDI
- Basic UDI-DI
- 695966495021000012Q EUDAMED
- 510(k) Number
- K172727 FDA UDI
- FDA Product Code
- PKL FDA UDI
- EMDN Code
- G0308010101 GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE EUDAMED
- GMDN Term
- Gastrointestinal endoscopic clip, short-term FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Market of Registration
- France 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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Flexible endoscopic biopsy forceps, single-use
Disposable Swinging Biopsy Forceps by Hangzhou AGS MedTech Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 — ZHEJIANG CHUANGXIANG 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
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 695966495021000012Q | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou AGS MedTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011718
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 45ff616a-d570-45f9-ace6-e79ed609668a 61 fields · synced Jun 18, 2026
- FDA UDI 74784ae9-d79d-438d-bcf2-564faf1899e8 34 fields · synced May 30, 2026