Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, short-term FDA UDI
- Device Name
- Hemoclip EUDAMED
- Model / Reference
- AG-5101-2300-135 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06959664914069 EUDAMEDFDA UDI
- Basic UDI-DI
- 6959664951010000129 EUDAMED
- 510(k) Number
- K172727 FDA UDI
- FDA Product Code
- PKL FDA UDI
- EMDN Code
- G030202 DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS EUDAMED
- GMDN Term
- Gastrointestinal endoscopic clip, short-term FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Hemoclip by Hangzhou AGS MedTech Co., Ltd. — Class IIb — 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 | 6959664951010000129 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 aad382ae-5e19-4e6b-9feb-8341d1047f5d 61 fields · synced Jul 14, 2026
- FDA UDI 3e9a2c44-dd56-457d-ad17-4be8e3de9452 33 fields · synced May 30, 2026