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Arnés de Pavlik (OP)
EUDAMEDClass I (EU MDR)
Ref OP115 XSRef OP115 M Ref OP115 L
by Prim, S.a.
Identity
- Trade Name
- Arnés de Pavlik (OP) EUDAMED
- Device Name
- Ortesis de Cadera EUDAMED
- Model / Reference
- OP115 XS EUDAMEDOP115 M EUDAMEDOP115 L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680926829 EUDAMED08426680848329 EUDAMED08426680926843 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 (OP) 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 (3)
- EUDAMED 8bc4f816-876f-437d-9c5a-8a1120427bbf 61 fields · synced Jul 22, 2026
- EUDAMED 356526bf-9390-47e4-9a76-f5b7994f99da 61 fields · synced May 17, 2026
- EUDAMED 407afa4a-a507-4e3d-a1e7-2d4accd6189b 61 fields · synced May 18, 2026