Identity
- Trade Name
- Wrist & thumb splint -A-M EUDAMEDWrist & thumb splint -Δ-M EUDAMED
- Device Name
- Wrist support EUDAMED
- Model / Reference
- 5506Α-Μ EUDAMED5506Δ-Μ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05206210199137 EUDAMED05206210199236 EUDAMED
- Basic UDI-DI
- 5206210WRISTVH EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Wrist & thumb splint -A-M by Μιχαλης Κουγιουμτζης Και Σια Ε.ε. — 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 | 5206210WRISTVH | Class I | Active |
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Manufacturer
- Manufacturer
- Μιχαλης Κουγιουμτζης Και Σια Ε.ε.
- EUDAMED SRN
- GR-MF-000015985
Sources (2)
- EUDAMED 8f32d7b3-2c42-4583-a454-5d82b097cc06 61 fields · synced Jul 10, 2026
- EUDAMED 594bd0f1-2ec2-4d54-bf82-978e159418cb 61 fields · synced May 19, 2026