← Back to catalogue
M-Pace Medial AFO - Right Extra Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref FH400R05
by Trulife Ltd
Identity
- Trade Name
- M-Pace Medial AFO - Right Extra Large EUDAMEDPace FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- Ankle foot orthosis EUDAMEDMatrix Pace AFO - Right X Large FDA UDI
- Model / Reference
- FH400R05 EUDAMEDFDA UDI
- Description
- Matrix Pace AFO - Right X Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05052893001898 EUDAMEDFDA UDI
- Basic UDI-DI
- 5052893CFMCQ EUDAMED
- Direct Marketing DI
- 05052893001898 EUDAMED
- FDA Product Code
- IQI FDA UDI
- EMDN Code
- Y06120602 ENERGY RETURN ANKLE-FOOT ORTHOSES EUDAMED
- GMDN Term
- Ankle/foot orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
M-Pace Medial AFO - Right Extra Large by Trulife Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5052893CFMCQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trulife Ltd
- EUDAMED SRN
- GB-MF-000015741
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 7a35f30f-8dc6-4912-9106-8b6c8a3b7546 61 fields · synced Aug 4, 2026
- FDA UDI 9b45cddb-fbb6-4bab-a691-1e8dfde9dd84 33 fields · synced May 25, 2026