Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

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

MD Atlas
77 Elektronika Műszeripari Kft

EUDAMED last updated this device on May 24, 2022

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: 05997345781273
Reference / catalog number: ULC001

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?

Manufacturer information

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

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: 05997345781273
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

Related devices

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

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