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Pantorrillera de Neopreno TOPLINE
EUDAMEDClass I (EU MDR)
Ref TL120 LRef TL120 MRef TLS220Ref TL120 XL
by Prim, S.a.
Identity
- Trade Name
- Pantorrillera de Neopreno TOPLINE EUDAMEDPantorrillera de Neopreno TOPLINE OS EUDAMED
- Device Name
- Ortesis Tibiales EUDAMED
- Model / Reference
- TL120 L EUDAMEDTL120 M EUDAMEDTLS220 EUDAMEDTL120 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680922067 EUDAMED08426680922050 EUDAMED08426680938563 EUDAMED08426680922074 EUDAMED
- Basic UDI-DI
- 843404825ORTESISTIBIAXY EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER 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
Pantorrillera de Neopreno TOPLINE 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 |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (4)
- EUDAMED f0e6cabb-73f6-4a0c-a15a-6e56a6c5bc7c 61 fields · synced Jul 29, 2026
- EUDAMED 84c1ecc5-91b6-4a32-8177-c1a6216f0312 61 fields · synced May 17, 2026
- EUDAMED a77ea2af-3614-4290-bed3-def67d5df3c8 61 fields · synced May 17, 2026
- EUDAMED b3023ffa-cf22-4f7d-9b0e-11eda720fe0d 61 fields · synced May 18, 2026