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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

5904292005208 — Class IIa MDD by Echo-Son SA

MD Atlas
Echo-Son SA

EUDAMED last updated this device on Apr 26, 2024

5904292005208

B-05904292005208

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Echo-Son SA
UDI-DI code: 05904292005208
Reference / catalog number: 5904292005208

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View device family (Basic UDI)

Manufacturer information

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

Related devices

5904292005048B-05904292005048On the market 5904292005147B-05904292005147On the market 5904292005154B-05904292005154On the market 5904292005161B-05904292005161On the market 5904292005000B-05904292005000On the market

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

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	Jun 14, 2016	May 31, 2024

Device identification

Trade name: not provided
UDI-DI code: 05904292005208
Basic UDI-DI: B-05904292005208
Reference / catalog number: 5904292005208
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: Sondy ultradźwiękowe są aplikacyjną częścią ultrasonografu, przeznaczoną do emisji i odbioru fali ultradźwiękowej, wykorzystywanej w diagnostyce ultrasonograficznej. Sondy tylko do ultrasonografów produkcji Echo-son S.A.
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.

Z11040299ULTRASOUND PROBES – OTHER

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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