Identity
- Trade Name
- MedTextile EUDAMED
- Device Name
- Elbow brace (with additional fixation) EUDAMED
- Model / Reference
- 8321 EUDAMED8321 - M beige EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03800232482820 EUDAMED
- Basic UDI-DI
- 3800232484442SR EUDAMED
- EMDN Code
- M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.) 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 | 3800232484442SR | Class I | Active |
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Manufacturer
- Manufacturer
- Medtex Swiss Ltd
- EUDAMED SRN
- BG-MF-000023453
Sources (1)
- EUDAMED 0b174a09-e760-4e8b-9c16-d59db15f29f5 61 fields · synced Jun 19, 2026