Identity
- Trade Name
- KENTAMED ACTIS-400 EUDAMED
- Device Name
- KENTAMED ACTIS-400 EUDAMED
- Model / Reference
- 10-11-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03800943000153 EUDAMED
- Basic UDI-DI
- 3800943ACTIS400P4 EUDAMED
- Direct Marketing DI
- 03800943000153 EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria 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
Kentamed Actis-400 by KENTAMED 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 | 3800943ACTIS400P4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- KENTAMED Ltd.
- EUDAMED SRN
- BG-MF-000022619
Sources (1)
- EUDAMED 18b9ecab-6589-495f-a274-daafadc3b522 61 fields · synced Jun 19, 2026