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Matrix Max AFO (X Large Right)
EUDAMEDFDA UDIClass I (EU MDR)
Ref FH250R05
by Trulife Ltd
Identity
- Trade Name
- Matrix Max AFO (X Large Right) EUDAMEDMatrix Max FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- Ankle foot orthosis EUDAMEDMatrix Max AFO (X Large Right) FDA UDI
- Model / Reference
- FH250R05 EUDAMEDFDA UDI
- Description
- Matrix Max AFO (X Large Right) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00645517538242 EUDAMEDFDA UDI
- Basic UDI-DI
- 5052893CFMCQ EUDAMED
- Direct Marketing DI
- 00645517538242 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 Max AFO (X 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 03994658-09de-4b87-b685-220c32f7db8f 61 fields · synced Jul 9, 2026
- FDA UDI a2d7bc14-58ee-44f8-8dc5-dba55e01c0b6 33 fields · synced May 30, 2026