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Ultrasonic Surgical Scalpel
EUDAMEDClass IIb (EU MDR)
Ref BSG22Model BSG22,BSG35,BSG45,OCBSG22,OCBSG35,OCBSG45
Identity
- Device Name
- Ultrasonic Surgical Scalpel EUDAMED
- Model / Reference
- BSG22,BSG35,BSG45,OCBSG22,OCBSG35,OCBSG45 EUDAMEDBSG22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464940847 EUDAMED
- Basic UDI-DI
- 697246494MD03010USS0026V 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
No
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 | 697246494MD03010USS0026V | 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 3b5a239f-d51c-4fa3-98eb-bc1bf138ac22 61 fields · synced Jun 19, 2026