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AQUARAY Balneo
EUDAMEDClass IIa (EU MDR)
Ref -Model AQUARAY Balneo, ORIONMED Balneo, ORIONMED Balneo Air Model AQUARAY, AQUANEA, ORIONMED
Identity
- Trade Name
- AQUARAY Balneo EUDAMEDAQUARAY EUDAMED
- Device Name
- Wanna do kąpieli balneologicznych EUDAMEDWanna terapeutyczna do automatycznego hydromasażu strefowego EUDAMED
- Model / Reference
- AQUARAY Balneo, ORIONMED Balneo, ORIONMED Balneo Air EUDAMED- EUDAMEDAQUARAY, AQUANEA, ORIONMED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903684800599 EUDAMED05903684800506 EUDAMED
- Basic UDI-DI
- 590368480M034A74 EUDAMED590368480M034BQ 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
AQUARAY 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 (2)
- EUDAMED 72d33422-54b0-44ec-9b0e-a39e1d74dd43 61 fields · synced Oct 6, 2026
- EUDAMED ffbffa6d-9474-4c44-8c6f-0995088cb66d 61 fields · synced May 18, 2026