Identity
- Trade Name
- DERMLITE EUDAMED
- Device Name
- DermLite DL1 EUDAMED
- Model / Reference
- DL1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08559970060368 EUDAMED
- Basic UDI-DI
- 085599700603678 EUDAMED
- EMDN Code
- Z12040108 DERMATOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Dermlite by DermLite LLC — 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 | 085599700603678 | Class I | Active |
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Manufacturer
- Manufacturer
- DermLite LLC
- EUDAMED SRN
- US-MF-000005170
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (1)
- EUDAMED 1bb79eeb-8a3a-4032-9f07-61a1584e33d9 61 fields · synced May 22, 2026