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Digital Image Receptors -Stationary
EUDAMEDClass IIa (EU MDR)
Ref Digital Image Receptors -Stationary
Identity
- Device Name
- Digital Image Receptors -Stationary EUDAMED
- Model / Reference
- Digital Image Receptors -Stationary EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00854344007719 EUDAMED
- Basic UDI-DI
- 0854344007Img_ReceptorSJM EUDAMED
- Direct Marketing DI
- 00854344007719 EUDAMED
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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 Image Receptors -Stationary by Varex Imaging Corporation — 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 | 0854344007Img_ReceptorSJM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Varex Imaging Corporation
- EUDAMED SRN
- US-MF-000028124
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (1)
- EUDAMED 08606f45-4ed1-45e6-9974-431cc6c6d839 61 fields · synced Jun 19, 2026