Identity
- Trade Name
- CareView 560RF EUDAMED
- Device Name
- X-ray Flat Panel Detector EUDAMED
- Model / Reference
- CareView 1800RF EUDAMED045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970597830455 EUDAMED
- Basic UDI-DI
- 697059783DynamicCR EUDAMED
- Direct Marketing DI
- 06970597830455 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY 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
Category: Stationary basic diagnostic x-ray system, digital
CareView 560RF by Careray Digital Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697059783DynamicCR | 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 ee27d874-a8a4-4b07-8e3a-30181190f832 61 fields · synced Jun 18, 2026