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Tobillera Elástica AQTIVO Skin
EUDAMEDClass I (EU MDR)
Ref P710BG SRef P710BG LRef P710BG XLRef P710BG M
by Prim, S.a.
Identity
- Trade Name
- Tobillera Elástica AQTIVO Skin EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- P710BG S EUDAMEDP710BG L EUDAMEDP710BG XL EUDAMEDP710BG M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048131167 EUDAMED08434048131143 EUDAMED08434048358885 EUDAMED08434048131150 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 AQTIVO Skin 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 (4)
- EUDAMED 472f7ec7-176c-4b06-a919-a0d9d0ccfdf7 61 fields · synced Oct 6, 2026
- EUDAMED 3058637a-f884-4444-b93d-4b1916961a8b 61 fields · synced May 16, 2026
- EUDAMED 2df4b73c-6b4b-4eef-9623-be76929cd010 61 fields · synced May 16, 2026
- EUDAMED 6337a566-d0ca-46c9-8dfe-6f4f11e48382 61 fields · synced May 16, 2026