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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

5904292005031 — Class IIa MDD by Echo-Son SA

MD Atlas
Echo-Son SA

EUDAMED last updated this device on Apr 26, 2024

5904292005031

B-05904292005031

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Echo-Son SA
UDI-DI code: 05904292005031
Reference / catalog number: 5904292005031

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Manufacturer information

Organization name: Echo-Son SA
SRN: PL-MF-000004830
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Aug 30, 2017	May 31, 2024

Device identification

Trade name: not provided
UDI-DI code: 05904292005031
Basic UDI-DI: B-05904292005031
Reference / catalog number: 5904292005031
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: PINIT to mały, przenośny, przyjazny w obsłudze ultrasonograf do nieinwazyjnego pomiaru objętości pęcherza moczowego oraz do podstawowego obrazowania i pomiarów narządów układu moczowego (narzędzie wolumetryczno– diagnostyczne).
Additional information URL: https://echoson.eu/skaner-pecherza/
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.

Z12080304ULTRASONIC BLADDER VOLUME SCANNERS

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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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.