Identity
- Trade Name
- DMX-600 EUDAMED
- Device Name
- DMX-600 EUDAMED
- Model / Reference
- 506 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809244065026 EUDAMED
- Basic UDI-DI
- 880924406DMX600F7 EUDAMED
- EMDN Code
- Z11030202 DIGITAL MAMMOGRAPHY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania 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
Dmx-600 by Genoray Co., Ltd. — 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 | 880924406DMX600F7 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GENORAY CO., Ltd.
- EUDAMED SRN
- KR-MF-000021014
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 83972955-130b-43ee-a763-91fd03940c9f 61 fields · synced Jun 18, 2026