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InnoGrace
EUDAMEDClass IIb (EU MDR)
Ref IBSG35Model IBSG22/35/45, IBSGBL22/35/45,IBSGPL22/35/45, ICBSG22/35/45, ICBSGBL22/35/45,ICBSGPL22/35/45,IFBSG22/35/45, IFBSGBL22/35/45, IFBSGPL22/35/45,IFCBSG22/35/45, IFCBSGBL22/35/45, IFCBSGPL22/35/45
Identity
- Trade Name
- InnoGrace EUDAMED
- Device Name
- Ultrasonic Surgical Scalpel EUDAMED
- Model / Reference
- IBSG22/35/45, IBSGBL22/35/45,IBSGPL22/35/45, ICBSG22/35/45, ICBSGBL22/35/45,ICBSGPL22/35/45,IFBSG22/35/45, IFBSGBL22/35/45, IFBSGPL22/35/45,IFCBSG22/35/45, IFCBSGBL22/35/45, IFCBSGPL22/35/45 EUDAMEDIBSG35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464941103 EUDAMED
- Basic UDI-DI
- 697246494MD03010USS0036X EUDAMED
- EMDN Code
- Z12010801 ULTRASONIC SCALPEL EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
InnoGrace 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 | 697246494MD03010USS0036X | 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 42449f03-c662-4423-9684-485d210f5332 61 fields · synced Jun 18, 2026