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Gibaud Ortho Malleocross Cavigliera Graduale - Tg 01
EUDAMEDClass I (EU MDR)
Ref 5G0614X10NB01
Identity
- Trade Name
- GIBAUD ORTHO MALLEOCROSS CAVIGLIERA GRADUALE - TG 01 EUDAMED
- Device Name
- Gibaud Ortho MALLEOCROSS – Cavigliera graduale EUDAMED
- Model / Reference
- 5G0614X10NB01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382242628 EUDAMED
- Basic UDI-DI
- 8054382245G0614QB 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
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 Ortho Malleocross Cavigliera Graduale - Tg 01 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 | 8054382245G0614QB | Class I | Active |
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Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED 974dd4bc-52c2-4b25-ba4d-69ca69cc6d72 61 fields · synced Jun 18, 2026