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Matrix AFO - Large Right
EUDAMEDFDA UDIClass I (EU MDR)
Ref FH200R04
by Trulife Ltd
Identity
- Trade Name
- Matrix AFO - Large Right EUDAMEDMatrix FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- Ankle foot orthosis EUDAMEDMatrix AFO (Large Right) (Max Weight 250lb/113kg) FDA UDI
- Model / Reference
- FH200R04 EUDAMEDFDA UDI
- Description
- Matrix AFO (Large Right) (Max Weight 250lb/113kg) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00645517413570 EUDAMEDFDA UDI
- Basic UDI-DI
- 5052893CFMCQ EUDAMED
- Direct Marketing DI
- 00645517413570 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
Matrix AFO - Large Right 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 |
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Manufacturer
- Manufacturer
- Trulife Ltd
- EUDAMED SRN
- GB-MF-000015741
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0cade678-a9e2-4be2-9644-9a6f07e21f44 61 fields · synced Jul 12, 2026
- FDA UDI b05e742d-500e-45c1-b16e-e0f74c25f7cb 33 fields · synced May 30, 2026