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Oasis Flat Bottom Chest Roll
EUDAMEDClass I (EU MDR)
Ref OA213Model PressureCare
by Trulife
Identity
- Trade Name
- Oasis Flat Bottom Chest Roll EUDAMED
- Device Name
- PressureCare EUDAMED
- Model / Reference
- PressureCare EUDAMEDOA213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00643293009291 EUDAMED
- Basic UDI-DI
- 00643293PressurecareDT EUDAMED
- Direct Marketing DI
- 00643293009291 EUDAMED
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Oasis Flat Bottom Chest Roll by Trulife — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00643293PressurecareDT | Class I | Active |
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Manufacturer
- Manufacturer
- Trulife
- EUDAMED SRN
- IE-MF-000003108
Sources (1)
- EUDAMED 203ab92f-b3f7-468b-ac68-df2900cc29b0 61 fields · synced Jun 18, 2026