Identity
- Trade Name
- Treatment Table EUDAMED
- Device Name
- Treatment Table EUDAMED
- Model / Reference
- ENB-101 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719880601004 EUDAMED
- Basic UDI-DI
- 47198806020187E EUDAMED
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Estonia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Dermatological laser beam guiding handpiece
Treatment Table by Enigma Care Co., Ltd. — Class I — 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 | 47198806020187E | Class I | Active |
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Manufacturer
- Manufacturer
- Enigma Care Co., Ltd.
- EUDAMED SRN
- TW-MF-000023349
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 9b9d433b-266c-4bc1-8cf1-81f0252c4b9c 61 fields · synced Jun 19, 2026