Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

5904292005000 — Class IIa MDD by Echo-Son SA

MD Atlas
Echo-Son SA

EUDAMED last updated this device on Jun 11, 2024

5904292005000

B-05904292005000

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Echo-Son SA
UDI-DI code: 05904292005000
Reference / catalog number: 5904292005000

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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 5904292005208B-05904292005208On 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

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

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

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Poland; available across 2 countries total.

Country	On market since	Until
PolandPrimary placement	Aug 22, 2017	Still on market
Spain	Apr 12, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05904292005000
Basic UDI-DI: B-05904292005000
Reference / catalog number: 5904292005000
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: ALBIT to mały, przyjazny w obsłudze ultrasonograf do zastosowań diagnostycznych w anastezji, intensywnej opiece, w chirurgii naczyniowej, w radiologii interwencyjnej, w badaniach układu mięśniowo-szkieletowego i małych narządów powierzchniowych. ALBIT w wersji Vascular wyposażony jest dodatkowo w gniazdo głowic mechanicznych, które umożliwiają zastosowanie go do aplikacji specjalistycznych takich jak: proktologia, ultrasonografia przez odbytnicza stercza.
Additional information URL: https://echoson.eu/albit-duplex-doppler-uniwersalny-przenosny/
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.

Z11040101INTERNAL ULTRASOUND 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

Become a partner of MD Atlas