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Bipolar Coagulation Forceps
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref AG-5464-0723Model 5461Series-5464Series510(k) K210406
Identity
- Device Name
- Bipolar Coagulation Forceps EUDAMED
- Model / Reference
- 5461Series-5464Series EUDAMEDAG-5464-0723 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959664913987 EUDAMED
- Basic UDI-DI
- 6959664954610000178 EUDAMED
- EMDN Code
- K0201010601 OPEN ELECTROSURGERY FORCEPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Bipolar Coagulation Forceps by Hangzhou AGS MedTech Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210406 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 6959664954610000178 | Class IIb | Active |
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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 3b2dd0fe-4756-4a90-86b7-2d789f3a3bef 85 fields · synced Jun 18, 2026
- FDA 510(k) K210406 1 fields · synced May 18, 2026