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Gait belts
EUDAMEDClass I (EU MDR)
Ref NHI-GB-001Model NHI-GB-001,NHI-GB-002,NHI-GB-003,NHI-GB-004,NHI-GB-005
Identity
- Device Name
- Gait belts EUDAMED
- Model / Reference
- NHI-GB-001,NHI-GB-002,NHI-GB-003,NHI-GB-004,NHI-GB-005 EUDAMEDNHI-GB-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08994468810061 EUDAMED
- Basic UDI-DI
- 899446881GB001MW EUDAMED
- EMDN Code
- Y060306 THORACOLUMBAR ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Gait belts by Pt Newlife Healthcare International — 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 | 899446881GB001MW | Class I | Active |
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Manufacturer
- Manufacturer
- Pt Newlife Healthcare International
- EUDAMED SRN
- ID-MF-000051541
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e6cc4129-41e5-4803-8e07-7fdc9a083c0d 61 fields · synced Aug 1, 2026