Identity
- Device Name
- AIDIA Luxe EUDAMED
- Model / Reference
- AIDIA Luxe EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800018422809 EUDAMED
- Basic UDI-DI
- 88000184SMBXXXXXXXWQ EUDAMED
- Direct Marketing DI
- 08800018422809 EUDAMED
- EMDN Code
- Z11030202 DIGITAL MAMMOGRAPHY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb 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
AIDIA Luxe by DRTECH Corporation — Class IIb — 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 | 88000184SMBXXXXXXXWQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- DRTECH Corporation
- EUDAMED SRN
- KR-MF-000012441
- Authorised Representative
- DRTECH Europe GmbH DE-AR-000011974
Sources (1)
- EUDAMED 6ff42c00-963a-44dd-9918-b59d58099393 61 fields · synced Jun 18, 2026