Identity
- Trade Name
- E2 Removable HD MiniSet Hardware EUDAMEDE2 Heavy-Duty MiniSet Removable Mounting Hardware FDA UDI
- Generic Name
- Wheelchair back rest positioner FDA UDI
- Device Name
- Invacare-Matrx Back Supports and Accessories EUDAMEDE2 Heavy-Duty MiniSet Removable Mounting Hardware (pair); includes E2 MiniSet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release design. FDA UDI
- Model / Reference
- E2MSHD EUDAMEDFDA UDI
- Description
- E2 Heavy-Duty MiniSet Removable Mounting Hardware (pair); includes E2 MiniSet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release design. FDA UDI
Identifiers
- Catalog Number
- E2MSHD FDA UDI
- Primary DI / UDI-DI
- 07540147001209 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 Removable HD MiniSet 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 (2)
- EUDAMED 35a263bf-fadd-4488-aaf0-cb98528034a1 61 fields · synced Jul 11, 2026
- FDA UDI 58e7c4e1-b103-498f-b7f0-04f7f4a687b1 35 fields · synced May 25, 2026