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Ultrasonic Surgical Scalpel
EUDAMEDClass IIb (EU MDR)
Ref SS17Model SS9,SS17,OSS9,OSS17Ref OSG45Model SG13,SG22.SG35,SG45,OSG13,OSG22,OSG35,OSG45,OBSG22,OBSG35,OBSG45Ref OSG35Ref RBSG35Model RSG13,RSG22,RSG35,RSG45,RBSG22,RBSG35,RBSG45Ref SS9Ref SG35Ref BSG45Model BSG22,BSG35,BSG45,OCBSG22,OCBSG35,OCBSG45Ref BSG35Ref OSS9Ref OCBSG35Ref OBSG35Ref OSG22Ref SG22Ref OBSG22Ref OSG13Ref OCBSG22Ref OCBSG45Ref RBSG22
Identity
- Device Name
- Ultrasonic Surgical Scalpel EUDAMED
- Model / Reference
- SS9,SS17,OSS9,OSS17 EUDAMEDSS17 EUDAMEDSG13,SG22.SG35,SG45,OSG13,OSG22,OSG35,OSG45,OBSG22,OBSG35,OBSG45 EUDAMEDOSG45 EUDAMEDOSG35 EUDAMEDRSG13,RSG22,RSG35,RSG45,RBSG22,RBSG35,RBSG45 EUDAMEDRBSG35 EUDAMEDSS9 EUDAMEDSG35 EUDAMEDBSG22,BSG35,BSG45,OCBSG22,OCBSG35,OCBSG45 EUDAMEDBSG45 EUDAMEDBSG35 EUDAMEDOSS9 EUDAMEDOCBSG35 EUDAMEDOBSG35 EUDAMEDOSG22 EUDAMEDSG22 EUDAMEDOBSG22 EUDAMEDOSG13 EUDAMEDOCBSG22 EUDAMEDOCBSG45 EUDAMEDRBSG22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464940366 EUDAMED06972464940403 EUDAMED06972464940397 EUDAMED06972464941073 EUDAMED06972464940359 EUDAMED06972464940335 EUDAMED06972464940861 EUDAMED06972464940854 EUDAMED06972464940410 EUDAMED06972464940885 EUDAMED06972464940441 EUDAMED06972464940380 EUDAMED06972464940328 EUDAMED06972464940434 EUDAMED06972464940373 EUDAMED06972464940878 EUDAMED06972464940892 EUDAMED06972464941066 EUDAMED
- Basic UDI-DI
- 697246494MD03002USS0027C EUDAMED697246494MD03002USS0017A EUDAMED697246494MD03006USS0019E EUDAMED697246494MD03010USS0026V 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
EUDAMEDEUDAMED
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 | 697246494MD03002USS0027C | 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 (18)
- EUDAMED f5691554-45ee-4e9f-9c18-113d3b760aa9 61 fields · synced Aug 1, 2026
- EUDAMED 73c966b3-035e-406d-8d08-c1f9e81b3ad5 61 fields · synced May 16, 2026
- EUDAMED 3b62c8e8-ac32-4526-be63-f9f363bb8556 61 fields · synced May 16, 2026
- EUDAMED e4851be5-3ef6-4a79-b0c6-f5a815ca389c 61 fields · synced May 16, 2026
- EUDAMED 1bd4e157-f200-4ed9-bf07-a03d6c6afd58 61 fields · synced May 17, 2026
- EUDAMED b41f91ea-f8d8-4a37-ac30-72c9633cefa3 61 fields · synced May 17, 2026
- EUDAMED 61498d18-76ca-49cf-ba85-e53e1b548334 61 fields · synced May 17, 2026
- EUDAMED de206080-ace8-41ab-9b79-93566fc4edab 61 fields · synced May 17, 2026
- EUDAMED 8f5f38cd-95f7-4562-8707-30834a2dc3e6 61 fields · synced May 17, 2026
- EUDAMED 8306cae8-ca5e-43ef-bdd6-a5c028b2a83d 61 fields · synced May 17, 2026
- EUDAMED 7f8e4e61-4797-4a95-8324-6049b5f52e0e 61 fields · synced May 17, 2026
- EUDAMED 8b03811f-49c0-4d5d-8e59-e800c256e143 61 fields · synced May 17, 2026
- EUDAMED 27cd5dc9-7667-4451-a7b3-ded0d9c305a8 61 fields · synced May 18, 2026
- EUDAMED 91b6a8f8-eda6-4650-bbf7-27d758cb0e9a 61 fields · synced May 18, 2026
- EUDAMED 6b65ad06-9cec-42f3-a90b-7afacb05e5fe 61 fields · synced May 18, 2026
- EUDAMED f691e146-b126-47da-a45a-d8732736426d 61 fields · synced May 18, 2026
- EUDAMED d23b4441-c3fa-4bfd-adb4-bd3fcf4df1c0 61 fields · synced May 18, 2026
- EUDAMED da720592-3238-4712-8252-af535017bedb 61 fields · synced May 19, 2026