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Duo=Profile With Wipeable Cover Size 16x16inch
EUDAMEDFDA UDIClass I (EU MDR)
Ref RDP006-1616Model Relax
by Trulife
Identity
- Trade Name
- Duo=Profile With Wipeable Cover Size 16x16inch EUDAMEDDuo-Profile FDA UDI
- Generic Name
- Medical cushion cover FDA UDI
- Device Name
- Relax EUDAMEDTrulife Wheelchair Cushion, Relax Duo-Profile Wipeable RDP006-16x16 FDA UDI
- Model / Reference
- Relax EUDAMEDRDP006-1616 EUDAMEDFDA UDI
- Description
- Trulife Wheelchair Cushion, Relax Duo-Profile Wipeable RDP006-16x16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293028452 EUDAMEDFDA UDI
- Basic UDI-DI
- 00643293RelaxU4 EUDAMED
- Direct Marketing DI
- 00643293028452 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
Duo=Profile With Wipeable Cover Size 16x16inch 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 f5d8447b-6ebf-4fe5-b842-f8bdf00cdd38 61 fields · synced Jul 16, 2026
- FDA UDI ae8bfd20-2e91-4666-814a-7cf97d4a31cf 33 fields · synced May 27, 2026