Identity
- Trade Name
- Muñequera envolvente MPK 2 EUDAMED
- Device Name
- Ortesis de Mano, Muñeca y/o Dedos EUDAMED
- Model / Reference
- MPK100 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048252466 EUDAMED
- Basic UDI-DI
- 843404825ORTESISMANOSXD EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Muñequera envolvente MPK 2 by Prim S.a. — 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 | 843404825ORTESISMANOSXD | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (2)
- EUDAMED e03a69a0-f393-4f79-bdac-842b94236389 61 fields · synced Aug 3, 2026
- EUDAMED 9e458812-b8f7-4b9e-a30a-3757945d5182 61 fields · synced Aug 3, 2026