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Poweo® 215 with ICU suspension, Scaleo elect. box, Linak jack, NiMh battery
EUDAMEDClass I (EU MDR)
Ref S16024Model Poweo® PassiveRef R4110020
Identity
- Trade Name
- Poweo® 215 with ICU suspension, Scaleo elect. box, Linak jack, NiMh battery EUDAMEDSCALEO Medical EUDAMED
- Device Name
- HORIZON P5 portable oxygen concentrator EUDAMED
- Model / Reference
- Poweo® Passive EUDAMEDS16024 EUDAMEDR4110020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664844002988 EUDAMED03664844000038 EUDAMED
- Basic UDI-DI
- 3664844POWLVPAH EUDAMEDB-03664844000038 EUDAMED
- Direct Marketing DI
- 03664844002988 EUDAMED
- EMDN Code
- V0805030102 ELECTRIC MOBILE LIFTS EUDAMEDZ12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Poweo® 215 with ICU suspension, Scaleo elect. box, Linak jack, NiMh battery by Scaleo Medical — Class I — MDD, MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 3664844POWLVPAH | Class I | Active |
| EUDAMED | European Union | CE/MDR | 3664844POWLVPAH | Class I | Active |
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Manufacturer
- Manufacturer
- Scaleo Medical
- EUDAMED SRN
- FR-MF-000002929
Sources (2)
- EUDAMED 791e195e-a060-44a3-b805-a9da26a887b1 61 fields · synced Jul 17, 2026
- EUDAMED 79780f0b-900d-46cf-ad6b-36ad15918b87 61 fields · synced Jul 17, 2026