Hemoclip
by Hangzhou AGS MedTech Co., Ltd. EUDAMEDGUDID
Active
Ref AG-55505-1950-090-9-1
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06959664917695 | Date14 Aug 2026 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number6959664951010000129 | Date11 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- Na
- Generic Name
- Gastrointestinal endoscopic clip, short-term
- Device Name
- Hemoclip
- Model / Reference
- AG-55505-1950-090-9-1
- Primary DI / UDI-DI
- 06959664917695
- Basic UDI-DI
- 6959664951010000129
- FDA Product Code
- PKL
- EMDN Code
- G030202 Digestive endoscopy, haemostasis clips
- GMDN Term
- Gastrointestinal endoscopic clip, short-term
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 876.4400
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Conditional
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
| Implantable | Yes | No |
Manufacturer details
- EUDAMED SRN
- CN-MF-000011718
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Hangzhou AGS MedTech Co., Ltd.
Properties
Other properties (18)
- 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: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No