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Tobillera Elástica c/almohadillas maleolares, AQTIVO Sport
EUDAMEDClass I (EU MDR)
Ref P705 XL
by Prim, S.a.
Identity
- Trade Name
- Tobillera Elástica c/almohadillas maleolares, AQTIVO Sport EUDAMEDTobillera Elástica c/almohadillas maleolares, AQTIVO Sport XL EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- P705 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048358847 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 Elástica c/almohadillas maleolares, AQTIVO Sport by Prim S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (2)
- EUDAMED 11df3f66-1327-4074-b997-9ae4069939da 61 fields · synced Oct 6, 2026
- EUDAMED 524dac69-5929-47f8-b049-a3f8615b33f9 61 fields · synced Jul 28, 2026