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Oxygen Regulator
EUDAMEDClass I (EU MDR)
Ref MR10054Model MR01 MR02 MR03 MR122 MR150 MR10041 MR10054 MR10235
Identity
- Device Name
- Oxygen Regulator EUDAMED
- Model / Reference
- MR01 MR02 MR03 MR122 MR150 MR10041 MR10054 MR10235 EUDAMEDMR10054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975883471169 EUDAMED
- Basic UDI-DI
- 697588347ORegulatorL2 EUDAMED
- EMDN Code
- R900901 INHALERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Oxygen Regulator by Hospital & Homecare Medical Device Co., Ltd. China — 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 | 697588347ORegulatorL2 | Class I | Active |
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Manufacturer
- Manufacturer
- Hospital & Homecare Medical Device Co., Ltd. China
- EUDAMED SRN
- CN-MF-000032014
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d972cf2e-247f-42d4-b829-3d004dcd43cc 61 fields · synced Oct 6, 2026