Identity
- Device Name
- Medical oxygen concentrator EUDAMED
- Model / Reference
- JAY-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934726614064 EUDAMED
- Basic UDI-DI
- B-06934726614064 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Medical oxygen concentrator by Longfian Scitech 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-06934726614064 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Longfian Scitech Co., Ltd.
- EUDAMED SRN
- CN-MF-000028163
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 7ad375e9-199a-4e1f-87da-27dd70c5694a 61 fields · synced Jun 19, 2026