Manufacturer

Thermofisher

Finland, Lithuania, United StatesLegal entities : Life Technologies Corporation; Thermo Fisher Life Sciences, Thermo Fisher Scientific Baltics UAB, Thermo Fisher Scientific Oy

Markets : Austria · Belgium · Denmark · Estonia · Finland · France · Germany · Italy · Lithuania · Netherlands · Norway · Spain · Sweden · United States

Approvals : EU – class A, C · United States (FDA) – 510(k) : 77 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : Italy 25 · France 22 · Germany 4 · Sweden 3 · Estonia 2 · Finland 2 · Norway 2 · Spain 2 · Belgium 1 · Denmark 1 · Netherlands 1

EU representative : Life Technologies Europe B.V. (Netherlands)

Website info.baltics@thermofisher.com

13 categories, 27 models including 27 on the market, 3 countries

Export to CSV

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Coronavirus - NA reagents	W0105041106	TaqPath™ 1-Step Multiplex Master Mix (No ROX)2 refs98/79 TaqPath™ COVID-19 Control2 refs98/79 TaqPath™ COVID-19 Control Dilution Buffer98/79 TaqPath™ COVID-19 RT-PCR Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Multiple viruses - multiplex assays - other	W0105070399	TaqPath™ 1-Step Multiplex Master Mix (no ROX)98/79 TaqPath™ COVID-19, Flu A/B, RSV Assay Kit98/79 TaqPath™ COVID-19, Flu A/B, RSV Control98/79 TaqPath™ COVID-19, Flu A/B, RSV Control Dilution Buffer98/79	– 98/79	EUDAMED record Report an error
Robotic sample processing systems - consumables	W02060185	Aliquoter secondary tubes Disposable Aliquoter Tips Grip Carrier2 refs Storage Cap2 refs	A IVDR	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	INDIKO3 refs Indiko Ultra3 refs	A IVDR	EUDAMED record Report an error
Control plasma for haemostasis	W0103020702	D-Dimer Control D-Dimer Control High	C IVDR	EUDAMED record Report an error
Lymphocyte separation media	W01030405	Dynabeads HLA Class I2 refs98/79 Dynabeads HLA Class II2 refs98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	MagMax Dx Viral/Pathogen NA Isolation Kit (A52735, A52736)2 refs MagMax Viral/Pathogen II Nucleic Acid Isolation Kit A48383	A IVDR	EUDAMED record Report an error
Samples analyses, plastic cuvettes	W0503010203	MULTICELL CUVETTES Tencell Cuvettes	A IVDR	EUDAMED record Report an error
Automated systems for the management of pre and post-analysis	W02060101	Ailex AS-2450 Analyzer Interface Module3 refs	A IVDR	EUDAMED record Report an error
Calibration plasma for haemostasis	W0103020701	D-Dimer Calibration Set	C IVDR	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer	C IVDR	EUDAMED record Report an error
Haematology reagents - other	W01030199	HbA1c Pretreatment Liquid2 refs	A IVDR	EUDAMED record Report an error
HIV 1 genotyping - NA reagents	W0105030108	HIV-1 Genotyping Kit A5440198/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.