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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

LIDA 300 Automatic Clinical… — IVDR Class A IVDR

MD Atlas
Linear Chemicals S.L.U

EUDAMED last updated this device on May 26, 2022

LIDA 300 Automatic Clinical Chemistry Analyzer

843528739360J4

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: 8435287393606
Reference / catalog number: 1805000

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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
When the user ignores this symbol and misuses the instrument, injury, wrong output results or property loss may be caused to the user.
CW008
Biohazard.

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: LIDA 300 Automatic Clinical Chemistry Analyzer
UDI-DI code: 8435287393606
Basic UDI-DI: 843528739360J4
Reference / catalog number: 1805000
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: LIDA 300 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)

W0201010102CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)

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.