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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

Urilyzer Cell Cuvettes — IVDR Class A IVDR by 77 Elektronika…

MD Atlas
77 Elektronika Műszeripari Kft

EUDAMED last updated this device on Feb 14, 2023

Urilyzer Cell Cuvettes

59973457CUV9W

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: 77 Elektronika Műszeripari Kft
UDI-DI code: 05997345782140
Reference / catalog number: ULC001

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Manufacturer information

Organization name: 77 Elektronika Műszeripari Kft
SRN: HU-MF-000004266
Manufacturer status: Active

Related devices

D71-80010059973457DEK7VOn the market D73-80020059973457DEK7VOn the market D72-80030059973457DEK7VOn the market D75-80010059973457DEK7VOn the market DocUReader 2 Pro59973457SAUA4SOn the market

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Hungary; available across 1 country total.

Placed on the market in Hungary; per-country availability dates not published.

Device identification

Trade name: Urilyzer Cell Cuvettes
UDI-DI code: 05997345782140
Basic UDI-DI: 59973457CUV9W
Reference / catalog number: ULC001
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 600
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02010785URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

IX 1006099-1Issued
Technical documentationNotified body: 0197Expiry: Feb 11, 2031
IX 1006099-2Issued
Technical documentationNotified body: 0197Expiry: Feb 11, 2031
HX 1006099-1Issued
Quality management systemNotified body: 0197Expiry: Feb 11, 2031