Manufacturer

Meridian Bioscience

Israel, United StatesLegal entities : Meridian Bioscience Inc., Meridian Bioscience Israel Ltd.

Markets : France · Italy · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 41 · PMA : 1 · class I, II, III · latest in 2025 · see on the FDA website

Public contracts won : France 3 · Italy 1

EU representative : Meridian Bioscience Europe S.r.l. (Italy)

Website

17 categories, 27 models including 27 on the market, 2 countries

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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
Faeces collection devices	W05019001	Para-Pak EcoFix Para-Pak® 10% Formalin Para-Pak® C&S Para-Pak® Clean Vial Para-Pak® CON-Trate® Tubes & Caps 2 others Para-Pak® SAF Para-Pak® Zn-PVA	A IVDR	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	BreathID® Hp Lab system VS01082 BreathID® Smart VS0700098/79 BreathID® Smart VS07000W	B IVDR, 98/79	EUDAMED record Report an error
Bacteriology controls - inf.imm.	W0105080801	alethia® Group B Streptococcus External Control Kit alethia® Pertussis External Control Kit	C IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Alethia Revogene®	A IVDR	EUDAMED record Report an error
All infectious diseases controls - NAT	W0105080808	Alethia CMV External Controls	C IVDR	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	alethia® Pertussis	C IVDR	EUDAMED record Report an error
Chlamydia trachomatis detection by NA reagents	W0105010117	Alethia Chlamydia	C IVDR	EUDAMED record Report an error
Cmv - NA reagents	W0105040205	Alethia CMV	C IVDR	EUDAMED record Report an error
DNA genomic preparation devices	W02050106	Revogene® Mock Pie	A IVDR	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	alethia® Gonorrhea	C IVDR	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	alethia® HSV 1&2	C IVDR	EUDAMED record Report an error
Other virology controls - inf.imm.	W0105080804	alethia® HSV 1&2 External Control Kit	C IVDR	EUDAMED record Report an error
Parasitology controls - inf.imm.	W0105080805	alethia® Malaria External Control Kit	C IVDR	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	alethia® Malaria	C IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	M-Prep DNA Sample Preparation	A IVDR	EUDAMED record Report an error
Strep. b detection by NA reagents	W0105011104	alethia® Group B Streptococcus	C IVDR	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Curian Analyzer	A IVDR	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.

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