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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

KROMA Automatic Clinical… — IVDR Class A IVDR

MD Atlas
Linear Chemicals S.L.U

EUDAMED last updated this device on May 25, 2022

KROMA Automatic Clinical Chemistry Analyzer

843528739300HJ

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Linear Chemicals S.L.U
UDI-DI code: 8435287393002
Reference / catalog number: 1800050

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Manufacturer information

Organization name: Linear Chemicals S.L.U
SRN: ES-MF-000003284
Manufacturer status: Active

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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.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW008
Biological Danger Icon. Contamination by Infected Liquids: near the waste liquids discharge outlet of the instrument, on the waste tank, near the washing sink pump and on the working area and it informs the user of the possible risk of biological contamination.
CW259
Electrical Danger Icon. Electrical Risk Danger: This icon, placed on the AC/DC power supply area and on the back of the instrument, near the main switch, informs the user of the electrical risk.
CW011
Warning of Moving Parts. Generic Danger Icon: is placed on the sampling probe protection defence or on the cover of the instrument and on the protection of the washing station of the reading cuvettes. It informs the user of the potential risk caused by moving mechanic parts when the protection defence or the cover is open or the washing station protection is removed.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: KROMA Automatic Clinical Chemistry Analyzer
UDI-DI code: 8435287393002
Basic UDI-DI: 843528739300HJ
Reference / catalog number: 1800050
Issuing entity: HIBCC

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: 1
Additional product description: KROMA Automatic Clinical Chemistry Analyzer
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201010101CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
Manufacturing date
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Software identification