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Digital Radiography System
EUDAMEDClass IIb (EU MDR)
Ref DigiEye 360TModel DigiEye 330 / DigiEye 330E / DigiEye 330P / DigiEye 330T / DigiEye 350 / DigiEye 350E / DigiEye 350P / DigiEye 350T / DigiEye 360 / DigiEye 360E / DigiEye 360P / DigiEye 360T
Identity
- Device Name
- Digital Radiography System EUDAMED
- Model / Reference
- DigiEye 330 / DigiEye 330E / DigiEye 330P / DigiEye 330T / DigiEye 350 / DigiEye 350E / DigiEye 350P / DigiEye 350T / DigiEye 360 / DigiEye 360E / DigiEye 360P / DigiEye 360T EUDAMEDDigiEye 360T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06903053049719 EUDAMED
- Basic UDI-DI
- 69449040AB0601000466 EUDAMED
- EMDN Code
- Z11031102 DIRECT DIGITAL TELERADIOGRAPHS EUDAMEDZ11031101 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 | 69449040AB0601000466 | 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 (2)
- EUDAMED 57c3f356-b457-4f79-b6a1-035ac86257b9 61 fields · synced Jun 19, 2026
- EUDAMED 1f555101-7c53-4a36-aac6-f3975ef2bec6 61 fields · synced Jun 19, 2026