Identity
- Trade Name
- HORIZON EUDAMED
- Device Name
- Pack Horizon® P5 portable oxygen concentrator - 8 cells EUDAMED
- Model / Reference
- R41508 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664844000076 EUDAMED
- Basic UDI-DI
- B-03664844000076 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Horizon by Scaleo Medical — 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-03664844000076 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Scaleo Medical
- EUDAMED SRN
- FR-MF-000002929
Sources (1)
- EUDAMED 94663c67-a989-4f1e-968b-ecbfacb1471a 61 fields · synced May 23, 2026