Identity
- Trade Name
- Férula extensora dedo XS EUDAMED
- Device Name
- Ortesis de Mano, Muñeca y/o Dedos EUDAMED
- Model / Reference
- PSL180 XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048417421 EUDAMED
- Basic UDI-DI
- 843404825ORTESISMANOSXD EUDAMED
- EMDN Code
- Y060603 FINGERS 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
Férula extensora dedo XS 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 89c4aa1a-6971-45b9-98a9-28d7415044ed 61 fields · synced Jun 19, 2026
- EUDAMED d632f437-4bad-4702-adfc-b150a3fe62f7 61 fields · synced Jun 19, 2026