Identity
- Trade Name
- TIBAX EUDAMED
- Device Name
- Ortesis Tibiales EUDAMED
- Model / Reference
- TIBAX EUDAMEDTIBAX BA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680668835 EUDAMED08426680849715 EUDAMED
- Basic UDI-DI
- 843404825ORTESISTIBIAXY EUDAMED
- EMDN Code
- Y061218 HIP-KNEE-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
Tibax 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 | 843404825ORTESISTIBIAXY | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (2)
- EUDAMED 39854f4e-de56-4c6a-bab7-399cd1215f9f 61 fields · synced Jul 29, 2026
- EUDAMED 8dcf1ea5-55cf-4d67-b81b-283b64601c67 61 fields · synced May 19, 2026