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Banda para Antiequino Textil
EUDAMEDClass I (EU MDR)
Ref ATX11 MR
by Prim, S.a.
Identity
- Trade Name
- Banda para Antiequino Textil EUDAMEDBanda para Antiequino Textil MR EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- ATX11 MR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680049689 EUDAMED
- Basic UDI-DI
- 843404825ORTESISTOBILLOTM EUDAMED
- EMDN Code
- Y06120602 ENERGY RETURN 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
Banda para Antiequino Textil 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 1eda160a-9341-4c64-9f93-09ed690f0e61 61 fields · synced Aug 3, 2026
- EUDAMED 71c439c0-7153-4283-bf85-5a60e705d19f 61 fields · synced Aug 3, 2026