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Tobillera Estabilizadora Vendaje 8 AIRTEX
EUDAMEDClass I (EU MDR)
Ref ATX820 M
by Prim, S.a.
Identity
- Trade Name
- Tobillera Estabilizadora Vendaje 8 AIRTEX EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- ATX820 M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048476978 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
Tobillera Estabilizadora Vendaje 8 AIRTEX 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 (2)
- EUDAMED e5c671c6-7a73-4654-85f0-e8732e7d1a2a 61 fields · synced Jun 18, 2026
- EUDAMED 9d29cfd6-b3b2-4c8d-950f-3838870e3528 61 fields · synced Jun 18, 2026