Identity
- Trade Name
- E2 EasySet Fixed Hardware EUDAMEDE2 Easy-Set Fixed Mounting Hardware FDA UDI
- Generic Name
- Wheelchair back rest positioner FDA UDI
- Device Name
- Invacare-Matrx Back Supports and Accessories EUDAMEDE2 Easy-Set Fixed Mounting Hardware (pair). Optional mounting hardware for Matrx E2 Backs (18H/20H). Requires tools for removal. FDA UDI
- Model / Reference
- ESFX, ESFXU EUDAMEDESFX FDA UDI
- Description
- E2 Easy-Set Fixed Mounting Hardware (pair). Optional mounting hardware for Matrx E2 Backs (18H/20H). Requires tools for removal. FDA UDI
Identifiers
- Catalog Number
- ESFX FDA UDI
- Primary DI / UDI-DI
- 07540147000899 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540147MATRXBACKS98 EUDAMED
- FDA Product Code
- KNN FDA UDI
- EMDN Code
- V0880,Y122499 EUDAMED
- GMDN Term
- Wheelchair back rest positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3920 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
E2 EasySet Fixed Hardware by Motion Concepts — 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 | 7540147MATRXBACKS98 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Motion Concepts
- EUDAMED SRN
- CA-MF-000004393
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 568249db-6935-49b6-a988-7ba0a1bf27db 61 fields · synced Jun 18, 2026
- FDA UDI 1d33485f-3c3b-43e4-98b0-dee08e815604 35 fields · synced May 30, 2026
- EUDAMED 568249db-6935-49b6-a988-7ba0a1bf27db-1 61 fields · synced Jun 9, 2026