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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

ORIONMED Balneo — Class IIa MDR by MEDEN-INMED SP. Z O.O.

MD Atlas
MEDEN-INMED SP. Z O.O.

EUDAMED last updated this device on Apr 8, 2026

ORIONMED Balneo

590368480M034A74

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDEN-INMED SP. Z O.O.
UDI-DI code: 05903684800605
Reference / catalog number: -

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View device family (Basic UDI)

Manufacturer information

Organization name: MEDEN-INMED SP. Z O.O.
SRN: PL-MF-000001670
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: ORIONMED Balneo
UDI-DI code: 05903684800605
Basic UDI-DI: 590368480M034A74
Reference / catalog number: -
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: AQUARAY Balneo, ORIONMED Balneo bathtub is a device intended for the automatic zone hydromassage treatments and balneological baths.
Additional information URL: https://sklep.meden.com.pl/wanny-balneologiczne-sklep-medyczny/1427-orionmed-balneo.html
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05903684800605

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z120618HYDROGYMNASTICS AND HYDROTHERAPY SYSTEMS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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