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OXUS Co., Ltd.
EUDAMEDClass IIb (EU MDR)
Ref R360211Model RAK-U06M2E, RAK-U03M2E
Identity
- Trade Name
- OXUS Co., Ltd. EUDAMED
- Device Name
- OXYGEN GENERATOR EUDAMED
- Model / Reference
- RAK-U06M2E, RAK-U03M2E EUDAMEDR360211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8800106800014VZ EUDAMED
- Basic UDI-DI
- B-8800106800014VZ EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb 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
OXUS Co., Ltd. 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-8800106800014VZ | Class IIb | Active |
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Manufacturer
- Manufacturer
- OXUS Co., Ltd.
- EUDAMED SRN
- KR-MF-000038598
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 15c1a530-f41b-45bf-833f-72b8bdd92864 61 fields · synced Jul 14, 2026