Identity
- Trade Name
- oxygen concentrator EUDAMED
- Device Name
- oxygen concentrator EUDAMED
- Model / Reference
- HORIZON S5 EUDAMEDEBVGQQ-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955623000361 EUDAMED
- Basic UDI-DI
- B-06955623000361 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 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-06955623000361 | 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 97ad6e2d-8ab9-4a71-aec7-58362680eb14 61 fields · synced Jun 19, 2026