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Duo-Profile With Mesh/Spacer Cover Size 18x16inch
EUDAMEDFDA UDIClass I (EU MDR)
Ref RDP009-1816Model Relax
by Trulife
Identity
- Trade Name
- Duo-Profile With Mesh/Spacer Cover Size 18x16inch EUDAMEDDuo-Profile FDA UDI
- Generic Name
- Wheelchair seat cushion FDA UDI
- Device Name
- Relax EUDAMEDTrulife Wheelchair Cushion, Relax Duo-Profile With Mesh Cover RDP009 1816 FDA UDI
- Model / Reference
- Relax EUDAMEDRDP009-1816 EUDAMEDRDP009 - 1816 FDA UDI
- Description
- Trulife Wheelchair Cushion, Relax Duo-Profile With Mesh Cover RDP009 1816 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293028803 EUDAMEDFDA UDI
- Basic UDI-DI
- 00643293RelaxU4 EUDAMED
- Direct Marketing DI
- 00643293028803 EUDAMED
- FDA Product Code
- IMP FDA UDI
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
- GMDN Term
- Wheelchair seat cushion 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 Mesh/Spacer Cover Size 18x16inch 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 f82df992-0608-470c-b5f1-72037d46e527 61 fields · synced Jul 12, 2026
- FDA UDI b6933133-c5ec-4c4f-bafa-e0ce99d96b21 33 fields · synced May 30, 2026