Identity
- Device Name
- Electrosurgical Generator EUDAMED
- Model / Reference
- AEU-120B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959664922330 EUDAMED
- Basic UDI-DI
- 6959664910810000132 EUDAMED
- EMDN Code
- Z12010904 ENDOSCOPIC ELECTROSURGICAL UNITS (ESU) EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Electrosurgical Generator by Hangzhou AGS MedTech Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6959664910810000132 | 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 (1)
- EUDAMED 8dd2b7ea-2587-47b4-abe3-6e5060eaebc5 61 fields · synced Oct 7, 2026