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Ultrasonic Surgical Scalpel
EUDAMEDClass IIb (EU MDR)
Ref RSG45Model RSG13,RSG22,RSG35,RSG45,RBSG22,RBSG35,RBSG45
Identity
- Device Name
- Ultrasonic Surgical Scalpel EUDAMED
- Model / Reference
- RSG13,RSG22,RSG35,RSG45,RBSG22,RBSG35,RBSG45 EUDAMEDRSG45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464941059 EUDAMED
- Basic UDI-DI
- 697246494MD03006USS0019E EUDAMED
- EMDN Code
- Z12010801 ULTRASONIC SCALPEL EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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 Surgical Scalpel by Innolcon Medical Technology (Suzhou) 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 | 697246494MD03006USS0019E | Class IIb | Active |
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Manufacturer
- Manufacturer
- Innolcon Medical Technology (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012689
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 12a957e1-2fd9-4d52-aaa8-be9db900b32b 61 fields · synced Jun 17, 2026