Identity
- Device Name
- Dome bag EUDAMED
- Model / Reference
- 53ND10065-MIC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290106596849 EUDAMED
- Basic UDI-DI
- B-07290106596849 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
Dome bag 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-07290106596849 | 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 e26d9741-5420-4f4b-a301-7c89ef702cfc 61 fields · synced Jul 10, 2026