Identity
- Trade Name
- OTD Dermatoscope EUDAMED
- Device Name
- OTD Dermatoscope EUDAMED
- Model / Reference
- BAL 2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060920310001 EUDAMED
- Basic UDI-DI
- 506092031dermatoscopeQP EUDAMED
- EMDN Code
- Z12040118 VIDEO DERMATOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
OTD Dermatoscope by DeepX Health Limited — 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 | 506092031dermatoscopeQP | Class I | Active |
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Manufacturer
- Manufacturer
- DeepX Health Limited
- EUDAMED SRN
- GB-MF-000011958
- Authorised Representative
- Medical Device Management Ltd IE-AR-000002496
Sources (1)
- EUDAMED 63d55058-025e-4e16-b1cc-2cb0e08a818b 61 fields · synced Jul 24, 2026