← Back to catalogue
Tobillera SPORT
EUDAMEDClass I (EU MDR)
Ref T116 PRO LRef T116 LRef T116 MRef T116 PRO M Ref T116 PRO S
by Prim, S.a.
Identity
- Trade Name
- Tobillera SPORT EUDAMEDTobillera SPORT L EUDAMEDTobillera SPORT M EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- T116 PRO L EUDAMEDT116 L EUDAMEDT116 M EUDAMEDT116 PRO M EUDAMEDT116 PRO S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048070640 EUDAMED08434048080441 EUDAMED08434048080458 EUDAMED08434048070657 EUDAMED08434048070664 EUDAMED
- Basic UDI-DI
- 843404825ORTESISTOBILLOTM EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDSpain 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 SPORT by Prim S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ankle/foot orthosis.
- Strp Only, Long, SA Wide Fl 12.5 E Stop — Becker Orthopedic Appliance Company · Class I
- Strp, SFL, 8.25in C Stop , AJT, SA, B — Becker Orthopedic Appliance Company · Class I
- Strp, Spl, WF Cal Pl, AJT, SA B, Free Mot LM/RL — Becker Orthopedic Appliance Company · Class I
- ALIMED ANKLE BRACE ALL AIR TUBE — AliMed, LLC · Class I
- Ankle support with 2 straps - Neoprene - onesize — ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. · Class I
- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (7)
- EUDAMED b7c37f3c-a888-4aac-9947-2e7b501fecea 61 fields · synced Sep 18, 2026
- EUDAMED e8878509-f004-4345-9725-4664dee45c29 61 fields · synced May 17, 2026
- EUDAMED 5dd4971e-eff3-4a02-a0c5-c614e4886dac 61 fields · synced May 17, 2026
- EUDAMED 208343f2-3d33-4714-8902-d912122d4def 61 fields · synced May 18, 2026
- EUDAMED 253e48c7-fe73-47c3-9fa0-e102091ceb96 61 fields · synced May 18, 2026
- EUDAMED b9500655-34b4-4f82-81df-1af8f145940d 61 fields · synced Jun 19, 2026
- EUDAMED b4b645f5-14da-4805-896c-6c114d39214c 61 fields · synced Jul 14, 2026