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Organization name
UDI-DI code
Reference / catalog number

00003850 — Class IIb MDD by ICZ.HEA a.s.

MD Atlas
ICZ.HEA a.s.

EUDAMED last updated this device on Dec 8, 2021

00003850

B-08594059060013

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ICZ.HEA a.s.
UDI-DI code: 08594059060013
Reference / catalog number: 00003850

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Manufacturer information

Organization name: ICZ.HEA a.s.
SRN: CZ-MF-000001703
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Oct 11, 2011	Still on market
Slovakia	Feb 28, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594059060013
Basic UDI-DI: B-08594059060013
Reference / catalog number: 00003850
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: AMIS*PACS FLEXSERVER G2 is determined for archivation of picture MD, communication with SW of WS, distribution of MD, comm. with HIS, it gives the reviews on pictures MD
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z110603PICTURE ARCHIVING AND COMMUNICATION 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

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.