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Tobillera Elástica c/almohadillas maleolares, AQTIVO Skin
EUDAMEDClass I (EU MDR)
Ref P705BG SRef P705BG XL
by Prim, S.a.
Identity
- Trade Name
- Tobillera Elástica c/almohadillas maleolares, AQTIVO Skin EUDAMEDTobillera Elástica c/almohadillas maleolares, AQTIVO Skin S EUDAMEDTobillera Elástica c/almohadillas maleolares, AQTIVO Skin XL EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- P705BG S EUDAMEDP705BG XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048105861 EUDAMED08434048358854 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
Tobillera Elástica c/almohadillas maleolares, AQTIVO Skin 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 e8503c3d-6124-487c-890b-73fd3ab08b37 61 fields · synced Oct 6, 2026
- EUDAMED d796161a-6312-498b-99c9-bfccd78f0129 61 fields · synced May 18, 2026
- EUDAMED 6cdec8ad-6245-4de4-bd00-c3909af44fd2 61 fields · synced Jul 13, 2026
- EUDAMED a6ec6a07-d977-4098-a6eb-dfd35111b768 61 fields · synced Jul 16, 2026