Identity
- Trade Name
- SYLFIRM EUDAMED
- Device Name
- SYLFIRM EUDAMED
- Model / Reference
- SYLFIRM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809502330064 EUDAMED
- Basic UDI-DI
- B-08809502330064 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Foot-switch, electrical
Sylfirm by VIOL Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809502330064 | Class IIb | Active |
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Manufacturer
- Manufacturer
- VIOL Co., Ltd.
- EUDAMED SRN
- KR-MF-000014556
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 19b3aeb7-2ef1-4811-a15d-056b8130d7fa 61 fields · synced Jun 18, 2026