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Antiequino NA400
EUDAMEDClass I (EU MDR)
Ref NA400 SRRef NA400 XLRRef NA400 MRRef NA400 LLRef NA400 SLRef NA400 ML
by Prim, S.a.
Identity
- Trade Name
- Antiequino NA400 EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- NA400 SR EUDAMEDNA400 XLR EUDAMEDNA400 MR EUDAMEDNA400 LL EUDAMEDNA400 SL EUDAMEDNA400 ML EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680805186 EUDAMED08426680805254 EUDAMED08426680805230 EUDAMED08426680805209 EUDAMED08426680805223 EUDAMED08426680805193 EUDAMED
- Basic UDI-DI
- 843404825ORTESISTOBILLOTM EUDAMED
- EMDN Code
- Y06120602 ENERGY RETURN ANKLE-FOOT ORTHOSES EUDAMEDY06120601 PASSIVE ANKLE-FOOT 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
Antiequino NA400 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 | 843404825ORTESISTOBILLOTM | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (6)
- EUDAMED 2ca0eaeb-913d-40e2-a8c1-4beec07ec3ac 61 fields · synced Jul 30, 2026
- EUDAMED 6048d546-bdf4-4a21-956d-af291c099587 61 fields · synced May 17, 2026
- EUDAMED 8bd7d344-5b31-4cf1-83d0-b3a782202fac 61 fields · synced May 17, 2026
- EUDAMED 30a4f13e-ed0a-421c-ba5c-3211895d98dc 61 fields · synced May 17, 2026
- EUDAMED 1b66b677-3b36-4b50-9b1a-12841211b443 61 fields · synced May 18, 2026
- EUDAMED 6548809f-e611-4e7e-a7f9-e4b9f25a1511 61 fields · synced May 19, 2026