Identity
- Trade Name
- CareView 750MT EUDAMED
- Device Name
- X-ray Flat Panel Detector EUDAMED
- Model / Reference
- CareView 750M EUDAMED040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970597830400 EUDAMED
- Basic UDI-DI
- 697059783Mammo9E EUDAMED
- Direct Marketing DI
- 06970597830400 EUDAMED
- EMDN Code
- Z11030202 DIGITAL MAMMOGRAPHY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
CareView 750MT by Careray Digital Medical Technology Co., Ltd. — Class IIa — 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 | 697059783Mammo9E | Class IIa | Active |
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Manufacturer
- Manufacturer
- CareRay Digital Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000007229
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 67cca6bb-22b3-4bab-ac12-91cbf987ffb0 61 fields · synced Jun 19, 2026