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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 Plus Automatic Clinical… — IVDR Class A IVDR

MD Atlas
Linear Chemicals S.L.U

EUDAMED last updated this device on May 25, 2022

KROMA Plus Automatic Clinical Chemistry Analyzer

843528739320HQ

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: 8435287393200
Reference / catalog number: 1800100

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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 Risk Danger. Electrical Danger Icon: This icon, placed on the AC/DC power supply and on the back of the instrument, near the main switch, informs the user of the electrical risk.
CW011
Warning of Moving Parts This icon is placed on the protection cover of the instrument. It informs the user of the potential risk caused by moving mechanic parts when the cover is opened 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 Plus Automatic Clinical Chemistry Analyzer
UDI-DI code: 8435287393200
Basic UDI-DI: 843528739320HQ
Reference / catalog number: 1800100
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 Plus 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