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Relax GelCell G2 Cushion Size 16x18inch
EUDAMEDFDA UDIClass I (EU MDR)
Ref RG005-1618Model Relax
by Trulife
Identity
- Trade Name
- Relax GelCell G2 Cushion Size 16x18inch EUDAMEDGelcell G2 FDA UDI
- Generic Name
- Wheelchair seat cushion FDA UDI
- Device Name
- Relax EUDAMEDTrulife Wheelchair Cushion, Relax GelCell RG005-1618 FDA UDI
- Model / Reference
- Relax EUDAMEDRG005-1618 EUDAMEDFDA UDI
- Description
- Trulife Wheelchair Cushion, Relax GelCell RG005-1618 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293010228 EUDAMEDFDA UDI
- Basic UDI-DI
- 00643293RelaxU4 EUDAMED
- Direct Marketing DI
- 00643293010228 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
Relax GelCell G2 Cushion Size 16x18inch 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 7fcdc949-f5a0-49a4-882a-245cf5e5848a 61 fields · synced Jul 14, 2026
- FDA UDI a5ac0dd6-02bb-4da5-867a-1f999b1bf0f3 33 fields · synced May 30, 2026