Identity
- Trade Name
- MedTextile EUDAMED
- Device Name
- Shoulder wrap fixative (desault’s bandage) EUDAMED
- Model / Reference
- 8013 EUDAMED8013 - XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03800232484411 EUDAMED
- Basic UDI-DI
- 3800232484411SE EUDAMED
- EMDN Code
- M030599 IMMOBILISATION SYSTEMS AND DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
MedTextile by Medtex Swiss 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 | 3800232484411SE | Class I | Active |
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Manufacturer
- Manufacturer
- Medtex Swiss Ltd
- EUDAMED SRN
- BG-MF-000023453
Sources (1)
- EUDAMED fac824c3-18d9-4806-a078-918705b56220 61 fields · synced Jun 19, 2026