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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

TEMIS Semi-automatic Clinical… — IVDR Class A IVDR

MD Atlas
Linear Chemicals S.L.U

EUDAMED last updated this device on May 26, 2022

TEMIS Semi-automatic Clinical Analyzer

843528739350HZ

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: 8435287393507
Reference / catalog number: 1803050

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Manufacturer information

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

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW259
The alternating current shall have fine grounding（zero voltage<5V）.  The alternating current shall be stable. It is forbidden to use power source together with appliance with great voltage. It is better to equip stable-voltage power source.  In the unstable voltage area, please use UPS to make sure the instrument can work normally.  When pulling out power source line, hold the connector plugs; do not hold power source line.  If smoke, peculiar smell or strange sound is found in the instrument, turn off the power immediately and contact with repair service center.

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: TEMIS Semi-automatic Clinical Analyzer
UDI-DI code: 8435287393507
Basic UDI-DI: 843528739350HZ
Reference / catalog number: 1803050
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: TEMIS Semi-automatic Clinical 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)

W0201020299LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER

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.