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Oxygen Concentrator for Medical use
EUDAMEDClass IIa (EU MDR)
Ref 303103Model OT-Elite10
Identity
- Trade Name
- Oxygen Concentrator for Medical use EUDAMED
- Device Name
- Oxygen Concentrator for Medical use EUDAMED
- Model / Reference
- OT-Elite10 EUDAMED303103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955623000101 EUDAMED
- Basic UDI-DI
- B-06955623000101 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Oxygen Concentrator for Medical use by Sysmed (china) Co., Ltd — Class IIa — 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-06955623000101 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SysMed (China) Co., Ltd.
- EUDAMED SRN
- CN-MF-000011904
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 547ae99d-b887-4523-8214-07caf96ec926 61 fields · synced Jul 31, 2026