Identity
- Trade Name
- POLSIERA SPORT TG1/S EUDAMED
- Device Name
- Poignet de force Gibaud T1 EUDAMED
- Model / Reference
- 6420VX-1/S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03322541051363 EUDAMED
- Basic UDI-DI
- 332254037KV EUDAMED
- Direct Marketing DI
- 03322541051363 EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Polsiera Sport Tg1/S by Gibaud — 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 | 332254037KV | Class I | Active |
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Manufacturer
- Manufacturer
- Gibaud
- EUDAMED SRN
- FR-MF-000014279
Sources (1)
- EUDAMED f68f5f31-bf0d-4d32-a961-190429f14d61 61 fields · synced Aug 3, 2026