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Gibaud Cavigliera Calzino Sottile - Tg 02
EUDAMEDClass I (EU MDR)
Ref 5A0612X00HD02
Identity
- Trade Name
- GIBAUD CAVIGLIERA CALZINO SOTTILE - TG 02 EUDAMED
- Device Name
- GIBAUD CAVIGLIERA CALZINO SOTTILE EUDAMED
- Model / Reference
- 5A0612X00HD02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382241607 EUDAMED
- Basic UDI-DI
- 8054382245A0612N5 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
Category: Ankle/foot orthosis
Gibaud Cavigliera Calzino Sottile - Tg 02 by Dual Sanitaly S.p.A. SB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8054382245A0612N5 | Class I | Active |
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Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED 43437b27-19ce-4e31-8486-68a9526e59fc 61 fields · synced Oct 7, 2026