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Duogel Standard Black Cover Size 20x16inch
EUDAMEDFDA UDIClass I (EU MDR)
Ref DC003-2016Model Relax
by Trulife
Identity
- Trade Name
- Duogel Standard Black Cover Size 20x16inch EUDAMEDDuo Standard Black cover FDA UDI
- Generic Name
- Medical cushion cover FDA UDI
- Device Name
- Relax EUDAMEDTrulife Relax Wheelchair Cover, Relax Duogel Cover DC003 20x16 FDA UDI
- Model / Reference
- Relax EUDAMEDDC003-2016 EUDAMEDDC003 - 2016 FDA UDI
- Description
- Trulife Relax Wheelchair Cover, Relax Duogel Cover DC003 20x16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293028759 EUDAMEDFDA UDI
- Basic UDI-DI
- 00643293RelaxU4 EUDAMED
- Direct Marketing DI
- 00643293028759 EUDAMED
- FDA Product Code
- IMP FDA UDI
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
- GMDN Term
- Medical cushion cover FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3920 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Duogel Standard Black Cover Size 20x16inch by Trulife — 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 | 00643293RelaxU4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Trulife
- EUDAMED SRN
- IE-MF-000003108
Sources (2)
- EUDAMED aefbb092-7cb4-4985-8761-caf424689cea 61 fields · synced Jun 18, 2026
- FDA UDI 86f70281-0656-41dd-98a1-4f4d837e584f 33 fields · synced May 30, 2026