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Digital Radiography System
EUDAMEDClass IIb (EU MDR)
Ref DigiEye U8 EliteModel DigiEye U9
Identity
- Device Name
- Digital Radiography System EUDAMED
- Model / Reference
- DigiEye U9 EUDAMEDDigiEye U8 Elite EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06903053090056 EUDAMED
- Basic UDI-DI
- 69449040AB050100505U EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY 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
Digital Radiography System by Shenzhen Mindray Bio-Medical Electronics 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 | 69449040AB050100505U | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9bacefc4-123d-40de-b7ea-3d6d75c28bf1 61 fields · synced Jun 19, 2026