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Tobillera con Banda Elástica "forma de 8"
EUDAMEDClass I (EU MDR)
Ref 28181P SRRef 28181P SLRef 28181P LLRef 28181P LR
by Prim, S.a.
Identity
- Trade Name
- Tobillera con Banda Elástica "forma de 8" EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- 28181P SR EUDAMED28181P SL EUDAMED28181P LL EUDAMED28181P LR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680747332 EUDAMED08426680747349 EUDAMED08426680747363 EUDAMED08426680747356 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 con Banda Elástica "forma de 8" 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 f90fe00c-f9ae-46f4-9419-402c175de37b 61 fields · synced Aug 4, 2026
- EUDAMED 1a5f7fd4-e8c3-4a2f-ade4-ad3064de55ac 61 fields · synced May 17, 2026
- EUDAMED d4b0a754-8826-4c20-ba8b-d0a27c9fc32e 61 fields · synced May 18, 2026
- EUDAMED 09594719-3544-4d0c-8e18-ce1edcaca034 61 fields · synced May 18, 2026