Identity
- Trade Name
- Arnés de Pavlik (IT) EUDAMED
- Device Name
- Ortesis de Cadera EUDAMED
- Model / Reference
- 116 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680752923 EUDAMED
- Basic UDI-DI
- 843404825ORTESISCADERAYT EUDAMED
- EMDN Code
- Y061215 HIP ORTHOSES (INCLUDING ABDUCTION 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
Arnés de Pavlik (IT) 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 | 843404825ORTESISCADERAYT | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (1)
- EUDAMED c21453b6-93b9-474c-b59f-ef24ce0a2e3e 61 fields · synced Jun 19, 2026