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High frequency surgical equipment
EUDAMEDClass IIb (EU MDR)
Ref E21-AModel E21, E21-A,E21-B, BFS-01, EFS-01, MFS-01, MFS-02
Identity
- Trade Name
- High frequency surgical equipment EUDAMED
- Device Name
- High frequency surgical equipment EUDAMED
- Model / Reference
- E21, E21-A,E21-B, BFS-01, EFS-01, MFS-01, MFS-02 EUDAMEDE21-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464945019 EUDAMED
- Basic UDI-DI
- 697246494MD03200HFSE001QE EUDAMED
- Direct Marketing DI
- 06972464945019 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
High frequency surgical equipment 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 | 697246494MD03200HFSE001QE | 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 61038da8-5f71-4890-826a-cb4dd06eada8 61 fields · synced Jun 18, 2026