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Polypectomy Snare (cold)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AG-5332-241523Model Normal handle (5331-5334, 5339 series)
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, short-term FDA UDI
- Device Name
- Polypectomy Snare (cold) EUDAMED
- Model / Reference
- Normal handle (5331-5334, 5339 series) EUDAMEDAG-5332-241523 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06959664909560 EUDAMEDFDA UDI
- Basic UDI-DI
- 6959664953310000152 EUDAMED
- 510(k) Number
- K172727 FDA UDI
- FDA Product Code
- PKL FDA UDI
- EMDN Code
- G03030199 POLYPECTOMY SNARES - OTHER 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Polypectomy Snare (cold) by Hangzhou AGS MedTech 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 | 6959664953310000152 | 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 a92032f7-0529-4d6a-8d7e-3cb6d4a242ac 61 fields · synced Jul 17, 2026
- FDA UDI 019dd1e9-6166-4654-9e23-70593f06f5cf 34 fields · synced May 30, 2026