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Elite Wedge Positioner
EUDAMEDFDA UDIClass I (EU MDR)
Ref ELP049Model PressureCare
by Trulife
Identity
- Trade Name
- Elite Wedge Positioner EUDAMEDElite FDA UDI
- Generic Name
- Operating table patient pressure distribution pad, reusable FDA UDI
- Device Name
- PressureCare EUDAMEDElite Wedge Positioner FDA UDI
- Model / Reference
- PressureCare EUDAMEDELP049 EUDAMEDFDA UDI
- Description
- Elite Wedge Positioner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293027479 EUDAMEDFDA UDI
- Basic UDI-DI
- 00643293PressurecareDT EUDAMED
- Direct Marketing DI
- 00643293027479 EUDAMED
- FDA Product Code
- JZR FDA UDI
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Operating table patient pressure distribution pad, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 866.4900 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
Elite Wedge Positioner 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 | 00643293PressurecareDT | 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 2359f12c-2467-482e-a047-5b8f02eb33fb 61 fields · synced Jun 17, 2026
- FDA UDI 55b140ed-20be-4f4c-ba06-d40da57d7312 33 fields · synced May 30, 2026