Identity
- Trade Name
- CPAP Tubing EUDAMED
- Device Name
- CPAP Tubing EUDAMED
- Model / Reference
- RAC EUDAMEDRAC-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872744283 EUDAMED
- Basic UDI-DI
- 471987274RAX-XXX5K EUDAMED
- EMDN Code
- R03010204 OXYGEN ADMINISTRATION TUBINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Oxygen administration tubing
CPAP Tubing by Acare Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471987274RAX-XXX5K | Class I | Active |
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Manufacturer
- Manufacturer
- Acare Technology Co., Ltd.
- EUDAMED SRN
- TW-MF-000031298
- Authorised Representative
- Surpass Biomedical Europe B.V. NL-AR-000038619
Sources (1)
- EUDAMED 53354c72-bc82-4d3e-885a-5fde008cdc54 61 fields · synced Jul 9, 2026