Identity
- Trade Name
- Dermatoscope Head for OMNI, LED EUDAMED
- Device Name
- Dermatoscope EUDAMED
- Model / Reference
- 818-023-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964000575901 EUDAMED
- Basic UDI-DI
- 896110278DRMS808QC EUDAMED
- EMDN Code
- Z12040108 DERMATOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Dermatoscope Head for OMNI, LED by Medical Devices (Pvt) Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 896110278DRMS808QC | Class I | Active |
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Manufacturer
- Manufacturer
- Medical Devices (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000021845
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 09eb6f43-c8e0-46a7-8f08-e35d8fed59a1 61 fields · synced Oct 5, 2026