Identity
- Trade Name
- MedTextile EUDAMED
- Device Name
- Wrist / thumb splint EUDAMED
- Model / Reference
- 8556 EUDAMED8556 S/M beige EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03800232483209 EUDAMED
- Basic UDI-DI
- 3800232483209SA EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - 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
Category: Hand/finger splint, reusable
MedTextile by Medtex Swiss Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand/finger splint, reusable.
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- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
- McKie Thumb Splint Adult — McKie Splints, LLC · Class I
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 | 3800232483209SA | Class I | Active |
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Manufacturer
- Manufacturer
- Medtex Swiss Ltd
- EUDAMED SRN
- BG-MF-000023453
Sources (1)
- EUDAMED 71928c98-6e0d-43f1-ba80-eef7034841cf 61 fields · synced Jun 17, 2026