Identity
- Trade Name
- SCARLET S EUDAMED
- Device Name
- SCARLET S EUDAMED
- Model / Reference
- SCARLET S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809502330057 EUDAMED
- Basic UDI-DI
- 880905233VIOLHFSUSSWC EUDAMED
- Direct Marketing DI
- 08809502330057 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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
Scarlet S by VIOL 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 | 880905233VIOLHFSUSSWC | 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 a676a7de-b638-4b52-a2ef-988ac2ef622d 61 fields · synced Jun 19, 2026