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ORIONMED Balneo
EUDAMEDClass IIa (EU MDR)
Ref -Model AQUARAY Balneo, ORIONMED Balneo, ORIONMED Balneo Air
Identity
- Trade Name
- ORIONMED Balneo EUDAMED
- Device Name
- Wanna do kąpieli balneologicznych EUDAMED
- Model / Reference
- AQUARAY Balneo, ORIONMED Balneo, ORIONMED Balneo Air EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903684800605 EUDAMED
- Basic UDI-DI
- 590368480M034A74 EUDAMED
- EMDN Code
- Z120618 HYDROGYMNASTICS AND HYDROTHERAPY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
ORIONMED Balneo by Meden Inmed Sp Z O O — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 590368480M034A74 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Meden-Inmed Sp. Z O.o.
- EUDAMED SRN
- PL-MF-000001670
Sources (1)
- EUDAMED 91c77bf1-3907-4c9b-9e15-f544ef375406 61 fields · synced Oct 7, 2026