Identity
- Device Name
- GaitBetter System EUDAMED
- Model / Reference
- GaitBetter System 2.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+B914GBD20/$$+72.0C* EUDAMED
- Basic UDI-DI
- ++B914GBD20TZ EUDAMED
- Direct Marketing DI
- *+B914GBD20/$$+72.0C* EUDAMED
- EMDN Code
- Z12069080,Z12069082 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
GaitBetter System by Goldengait Ltd — 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 | ++B914GBD20TZ | Class I | Active |
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Manufacturer
- Manufacturer
- GoldenGait Ltd.
- EUDAMED SRN
- IL-MF-000038393
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 95d086f9-b897-4453-a98e-660f22f37347 61 fields · synced Jul 10, 2026