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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 iT Automatic Immunological… — IVDR Class A IVDR

MD Atlas
Linear Chemicals S.L.U

EUDAMED last updated this device on May 26, 2022

KROMA iT Automatic Immunological Analyzer

843528739310HM

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: 8435287393101
Reference / catalog number: 3800050

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Manufacturer information

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

Critical warnings

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

CW011
Warning of Moving Parts. Generic Danger Icon: This icon is placed on the sampling probe protection defence 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 is opened or the washing station protection is removed.
CW259
Electrical Risk Danger. Electrical Danger Icon: 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.

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 iT Automatic Immunological Analyzer
UDI-DI code: 8435287393101
Basic UDI-DI: 843528739310HM
Reference / catalog number: 3800050
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 iT is an autimatic analizer for quantitative determination whit application in clinical chemistry and immunoassays.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201020101AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)

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

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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.