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U-Pace, Universal Posterior Lateral AFO – Right
EUDAMEDClass I (EU MDR)
Ref FH460R02
by Trulife Ltd
Identity
- Trade Name
- U-Pace, Universal Posterior Lateral AFO – Right EUDAMED
- Device Name
- Ankle foot orthosis EUDAMED
- Model / Reference
- FH460R02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05052893002932 EUDAMED
- Basic UDI-DI
- 5052893CFMCQ EUDAMED
- Direct Marketing DI
- 05052893002932 EUDAMED
- EMDN Code
- Y06120602 ENERGY RETURN ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
U-Pace, Universal Posterior Lateral AFO – Right by Trulife 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 | 5052893CFMCQ | Class I | Active |
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Manufacturer
- Manufacturer
- Trulife Ltd
- EUDAMED SRN
- GB-MF-000015741
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 976bff9c-57f2-4005-8cfc-9b92b6b5f3fe 61 fields · synced Aug 3, 2026