Identity
- Device Name
- C-ARM COVER EUDAMED
- Model / Reference
- 53ND5200T-MIC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290106599369 EUDAMED
- Basic UDI-DI
- B-07290106599369 EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
C-Arm Cover by Sion Biotext Medical Ltd — Class I — 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-07290106599369 | Class I | Active |
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Manufacturer
- Manufacturer
- Sion Biotext Medical Ltd.
- EUDAMED SRN
- IL-MF-000012169
- Authorised Representative
- Theo Manufacturing B.V. NL-AR-000006691
Sources (1)
- EUDAMED 462bf486-925f-432e-a3e1-8f5df140c631 61 fields · synced Jul 15, 2026