Identity
- Device Name
- Digital Radiography System EUDAMED
- Model / Reference
- ASR-6850P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950743810067 EUDAMED
- Basic UDI-DI
- B-06950743810067 EUDAMED
- EMDN Code
- Z11031102 DIRECT DIGITAL TELERADIOGRAPHS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Digital Radiography System by Shenzhen Anke High-Tech Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06950743810067 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Anke High-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000016473
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9e9e1c8e-0de6-450f-8e92-473e6420cd58 61 fields · synced Jun 18, 2026