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Oasis + Heel Pads
EUDAMEDClass I (EU MDR)
Ref OP130Model PressureCare
by Trulife
Identity
- Trade Name
- Oasis + Heel Pads EUDAMED
- Device Name
- PressureCare EUDAMED
- Model / Reference
- PressureCare EUDAMEDOP130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00643293025772 EUDAMED
- Basic UDI-DI
- 00643293PressurecareDT EUDAMED
- Direct Marketing DI
- 00643293025772 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 + Heel Pads 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 fd97e25b-5c70-4814-9005-12ac48fad8bb 61 fields · synced Jul 29, 2026