Identity
- Trade Name
- Care EUDAMED
- Device Name
- Oxygen Concentrator EUDAMED
- Model / Reference
- ZY-5AF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971072050085 EUDAMED
- Basic UDI-DI
- B-06971072050085 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece 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
Care by Foshan Care Medical Technology 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-06971072050085 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Foshan Care Medical Technology Co. Ltd.
- EUDAMED SRN
- CN-MF-000018871
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED 1b8f0759-ede1-4008-ab37-1f4ef5356cd3 61 fields · synced May 23, 2026