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Organization name
UDI-DI code
Reference / catalog number

Aquabela — Class IIa MDR by Medexim, spol. s r.o.

MD Atlas
Medexim, spol. s r.o.

EUDAMED last updated this device on Apr 20, 2022

Aquabela

858800918203KP

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Medexim, spol. s r.o.
UDI-DI code: 08588009182337
Reference / catalog number: Aquabela

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View device family (Basic UDI)

Manufacturer information

Organization name: Medexim, spol. s r.o.
SRN: SK-MF-000015788
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.

CW275
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement	Mar 24, 2020	Jun 30, 2023

Device identification

Trade name: Aquabela
UDI-DI code: 08588009182337
Basic UDI-DI: 858800918203KP
Reference / catalog number: Aquabela
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: Balneological hydromassage device
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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