Identity
- Trade Name
- Ultrasonic Generator EUDAMED
- Device Name
- Ultrasonic Generator EUDAMED
- Model / Reference
- - EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974065622306 EUDAMED06974065620630 EUDAMED
- Basic UDI-DI
- 697406562601GBQ EUDAMED
- EMDN Code
- Z12010801 ULTRASONIC SCALPEL EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Ultrasonic Generator by Surgsci Medical 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 | 697406562601GBQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Surgsci Medical Ltd.
- EUDAMED SRN
- CN-MF-000029791
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 9ddbaaa2-a0d0-46fd-8cc4-770f16ccefbf 61 fields · synced Jul 27, 2026
- EUDAMED 984d0d93-8954-445f-b42a-fa73c6517d2f 61 fields · synced May 19, 2026