Identity
- Trade Name
- AIDIA EUDAMED
- Device Name
- Digital Mammography system EUDAMED
- Model / Reference
- RMF-2000B EUDAMEDRMF-2000V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800018423103 EUDAMED08800018423202 EUDAMED
- Basic UDI-DI
- B-08800018423103 EUDAMEDB-08800018423202 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aidia by DRTECH Corporation — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800018423103 | 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 (2)
- EUDAMED 6ffa72c7-5308-4462-8d70-17dbda8de5d4 61 fields · synced Jul 10, 2026
- EUDAMED cece7915-f8f6-4995-818d-b5b67fad7664 61 fields · synced May 17, 2026