Identity
- Trade Name
- Protect E2 Standard Cover (IC) EUDAMEDMatrx Protect E2 Standard Infection Control Cover FDA UDI
- Generic Name
- Wheelchair back rest FDA UDI
- Device Name
- Invacare-Matrx Back Supports and Accessories EUDAMEDOptional Infection Control (Protect) Cover for Matrx E2S (Standard) Backs. FDA UDI
- Model / Reference
- PROTE2Swwhh EUDAMEDPROTE2S FDA UDI
- Description
- Optional Infection Control (Protect) Cover for Matrx E2S (Standard) Backs. FDA UDI
Identifiers
- Catalog Number
- PROTE2Swwhh FDA UDI
- Primary DI / UDI-DI
- 07540147000943 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540147MATRXBACKS98 EUDAMED
- Direct Marketing DI
- 07540147000943 EUDAMED
- FDA Product Code
- IMP FDA UDI
- EMDN Code
- V080302,Y122499 EUDAMED
- GMDN Term
- Wheelchair back rest 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
Protect E2 Standard Cover (IC) 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 d7b89f0a-be9d-4c86-b33f-fa7793352215 61 fields · synced Jun 19, 2026
- FDA UDI 2d21b6f9-28a0-4acb-a16e-7fa9dee626fd 35 fields · synced May 30, 2026