Identity
- Trade Name
- BARRIER WIPE 100pk x 20bx SION CEE EUDAMED
- Device Name
- Impregnated wipes EUDAMED
- Model / Reference
- 54W211-1206-913 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290101427803 EUDAMED
- Basic UDI-DI
- 729010142WIPEAV EUDAMED
- Direct Marketing DI
- 07290101427803 EUDAMED
- EMDN Code
- A108004 PROTECTIVE FILMS / SPRAYS FOR PERISTOMAL SKIN EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Latvia 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
BARRIER WIPE 100pk x 20bx SION CEE by Sion Biotext Medical Ltd — Class I — 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 | 729010142WIPEAV | 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 3684188b-a79a-4d79-b6d3-cce01fbd055d 61 fields · synced Jun 20, 2026