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Organization name
UDI-DI code
Reference / catalog number

5904292005048 — Class IIa MDD by Echo-Son SA

MD Atlas
Echo-Son SA

EUDAMED last updated this device on Apr 26, 2024

5904292005048

B-05904292005048

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Echo-Son SA
UDI-DI code: 05904292005048
Reference / catalog number: 5904292005048

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View device family (Basic UDI)

Manufacturer information

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

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Critical warnings

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

CW138
Urządzenie emituje fale ultradźwiękowe dlatego należy zapoznać się z bezpiecznym używaniem urządzenia

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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: 05904292005048
Basic UDI-DI: B-05904292005048
Reference / catalog number: 5904292005048
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: PIROP - Ultradźwiękowy ultrasonograf biometryczny do biometrii soczewki, badania oka i pachymetrii (A+B+P Scan). A- SCAN - biometria soczewki: Aparat PIROP w trybie A-scan z głowicą OA 12 MHz umożliwia pomiar osiowej długości gałki ocznej AXL, głębokości przedniej komory (AC), grubości soczewki (LENS) i grubości ciała szklistego (VITR) Aplikacje stosowane w systemie A-scan umożliwiają obliczenie mocy IOL dla implantów soczewki wewnątrzgałkowej. B - SCAN - diagnozowanie zmian struktur oka i przeprowadzenie pomiarów różnych struktur oka. PACHYMETR - biometria rogówki: do pomiarów grubości rogówki i utworzenia mapy pomiarowej.
Additional information URL: https://echoson.eu/okulistyka-i-stomatologia/
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.

Z12120102COMPUTERISED OPTICAL BIOMETERS

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.