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Antiequino Textil
EUDAMEDClass I (EU MDR)
Ref ATX01 S Ref ATX01 L
by Prim, S.a.
Identity
- Trade Name
- Antiequino Textil EUDAMEDAntiequino Textil S EUDAMEDAntiequino Textil L EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- ATX01 S EUDAMEDATX01 L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680049573 EUDAMED08426680049658 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
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 (4)
- EUDAMED 72fb000e-9a72-44d9-814f-fb151241337d 61 fields · synced Jul 15, 2026
- EUDAMED 7e63ef94-46f2-4dcc-b68b-936a1fd703a1 61 fields · synced May 17, 2026
- EUDAMED ad62f5ba-db1d-4905-ab62-f6b122cac105 61 fields · synced Jun 20, 2026
- EUDAMED ad01d713-e571-41b8-bd49-671d523e1aeb 61 fields · synced Jul 15, 2026