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High frequency surgical equipment
EUDAMEDClass IIb (EU MDR)
Ref E21Model E21, E21-A,E21-B, BFS-01, EFS-01, MFS-01, MFS-02Ref MFS-01Ref MFS-02Ref EFS-01
Identity
- Trade Name
- High frequency surgical equipment EUDAMEDHigh frequency surgical equipment-Foot switch EUDAMED
- Device Name
- High frequency surgical equipment EUDAMED
- Model / Reference
- E21, E21-A,E21-B, BFS-01, EFS-01, MFS-01, MFS-02 EUDAMEDE21 EUDAMEDMFS-01 EUDAMEDMFS-02 EUDAMEDEFS-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464945002 EUDAMED06972464945200 EUDAMED06972464945217 EUDAMED06972464945231 EUDAMED
- Basic UDI-DI
- 697246494MD03200HFSE001QE EUDAMED
- Direct Marketing DI
- 06972464945002 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
Category: Foot-switch, electrical
High frequency surgical equipment by Innolcon Medical Technology (Suzhou) Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (4)
- EUDAMED 64e5bb02-5076-4b4e-8065-ef14b3cf355e 61 fields · synced Sep 30, 2026
- EUDAMED b935fe96-2d28-47a6-bdae-6fb97c8f5980 61 fields · synced May 17, 2026
- EUDAMED 6839d812-9c94-4b8f-9f8d-f1ed8758a420 61 fields · synced May 18, 2026
- EUDAMED ddc03c79-0276-4f8f-8615-cc667f56c29b 61 fields · synced May 18, 2026