Identity
- Trade Name
- MedTextile EUDAMED
- Device Name
- Posture brace with stays (hard fixation) EUDAMED
- Model / Reference
- 2015 EUDAMED2015 - XL/XXL - I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03800232484138 EUDAMED
- Basic UDI-DI
- 3800232484114S5 EUDAMED
- EMDN Code
- M03040299 ELASTIC SUPPORT BANDAGES - 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 | 3800232484114S5 | Class I | Active |
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Manufacturer
- Manufacturer
- Medtex Swiss Ltd
- EUDAMED SRN
- BG-MF-000023453
Sources (1)
- EUDAMED 1b9fa897-2b2c-41cd-ada6-32c57a38a9b7 61 fields · synced Jun 19, 2026