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Rak-U06m2e, Rak-U03m2e
EUDAMEDClass IIb (EU MDR)
Ref R360211Model RAK-U06M2E, RAK-U03M2E
Identity
- Trade Name
- RAK-U06M2E, RAK-U03M2E EUDAMED
- Model / Reference
- RAK-U06M2E, RAK-U03M2E EUDAMEDR360211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-KR-MF-000038598DM EUDAMED
- Basic UDI-DI
- B-KR-MF-000038598DM EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Rak-U06m2e, Rak-U03m2e by OXUS Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-KR-MF-000038598DM | Class IIb | Active |
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Manufacturer
- Manufacturer
- OXUS Co., Ltd.
- EUDAMED SRN
- KR-MF-000038598
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (1)
- EUDAMED 16c54a1f-017b-426a-a08e-0565297b2042 61 fields · synced Jul 21, 2026