← Back to catalogue
Ortesi Polso e Mano 2.1
EUDAMEDClass I (EU MDR)
Ref 2.1Ti S RRef 2.1Ti L RRef 2.1Ti L LRef 2.1Ti S LRef 2.1Ti M L
by Prim, S.a.
Identity
- Trade Name
- Ortesi Polso e Mano 2.1 EUDAMED
- Device Name
- Ortesis de Mano, Muñeca y/o Dedos EUDAMED
- Model / Reference
- 2.1Ti S R EUDAMED2.1Ti L R EUDAMED2.1Ti L L EUDAMED2.1Ti S L EUDAMED2.1Ti M L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680713399 EUDAMED08426680713436 EUDAMED08426680713429 EUDAMED08426680713382 EUDAMED08426680713405 EUDAMED
- Basic UDI-DI
- 843404825ORTESISMANOSXD EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDItaly 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
Ortesi Polso e Mano 2.1 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 | 843404825ORTESISMANOSXD | 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 (5)
- EUDAMED cafac68a-b074-4104-9b44-0952507fa834 61 fields · synced Jul 16, 2026
- EUDAMED 39003dd1-4821-4e4f-8658-c0e89e27a5f2 61 fields · synced May 16, 2026
- EUDAMED eb6d9c0b-2af9-4543-a980-b5c5cb521df0 61 fields · synced May 16, 2026
- EUDAMED 000db5ed-0078-4b05-9d28-72668eb01ad0 61 fields · synced May 17, 2026
- EUDAMED 9a70eccd-0eb2-46b2-9d6d-9c4b77774b07 61 fields · synced May 19, 2026