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Tobillera Estabilizadora Vendaje 8 AIRTEX
EUDAMEDClass I (EU MDR)
Ref ATX820 XLRef ATX820 L
by Prim, S.a.
Identity
- Trade Name
- Tobillera Estabilizadora Vendaje 8 AIRTEX EUDAMEDTobillera Estabilizadora Vendaje 8 AIRTEX XL EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- ATX820 XL EUDAMEDATX820 L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048476992 EUDAMED08434048476985 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 Estabilizadora Vendaje 8 AIRTEX by Prim S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 (4)
- EUDAMED 3dab9344-460d-4075-aa5b-1c99f8396c31 61 fields · synced Oct 6, 2026
- EUDAMED 6f120fd1-38db-4109-a991-60765585ef54 61 fields · synced May 19, 2026
- EUDAMED c75ee411-7d1b-4306-bcfc-698db0f3b7e9 61 fields · synced Jun 19, 2026
- EUDAMED f46e1a53-b574-4c59-9463-d5ef87e73134 61 fields · synced Jul 12, 2026