Identity
- Trade Name
- GIBAUD CINTURA PIUMA cm 28 - TG. E/4 EUDAMED
- Device Name
- GIBAUD CINTURA PIUMA cm 28 EUDAMED
- Model / Reference
- 5A0125X00AAE4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382240549 EUDAMED
- Basic UDI-DI
- 8054382245A0125MM EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER 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
Yes
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
GIBAUD CINTURA PIUMA cm 28 - TG. E/4 by Dual Sanitaly S.p.A. SB — 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 | 8054382245A0125MM | Class I | Active |
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Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED 15ecaeb1-c7b2-43e2-a8a7-d0347b10ec78 61 fields · synced Jul 13, 2026