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Tobillera Férula/Cinchas AIRTEX
EUDAMEDClass I (EU MDR)
Ref ATX830 MLRef ATX830 SLRef ATX830 LR
by Prim, S.a.
Identity
- Trade Name
- Tobillera Férula/Cinchas AIRTEX EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- ATX830 ML EUDAMEDATX830 SL EUDAMEDATX830 LR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048477036 EUDAMED08434048477012 EUDAMED08434048477043 EUDAMED
- Basic UDI-DI
- 843404825ORTESISTOBILLOTM EUDAMED
- EMDN Code
- Y06120601 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
Category: Ankle/foot orthosis
Tobillera Férula/Cinchas AIRTEX by Prim S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (5)
- EUDAMED 8da7c7a3-f6c9-4a44-9b3d-4dc858a604c9 61 fields · synced Jul 15, 2026
- EUDAMED d4bceba8-6514-4331-a534-73606fe46191 61 fields · synced May 17, 2026
- EUDAMED 16750bd7-7f11-4ddf-927c-e39951bcf0ae 61 fields · synced May 18, 2026
- EUDAMED 64558efd-bc2a-4ff0-91a7-2151c1c3e1f1 61 fields · synced Jul 9, 2026
- EUDAMED ef4fd59c-1bed-4ade-bc43-549a22d41ad4 61 fields · synced Jul 15, 2026