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APPOLON BIOTECK

France·FR-MF-000022234

Last updated September 18, 2026

About

Appolon Bioteck was founded in 2011 and specialises in the development, manufacturing and marketing of "in vitro" diagnostic devices

Translated from the manufacturer's own website. Source

What APPOLON BIOTECK makes

Appolon Bioteck manufactures in vitro diagnostic (IVD) devices, including molecular assays like the SARS-CoV-2 RT-qPCR detection kit and multiplex respiratory pathogen tests such as RespiGUARD4plex. Their portfolio also includes automated extraction systems like ABility Smart Extract, genetic analysis tools like HLAB27GUARD, and coagulation monitoring devices such as ThromboGUARD FII FV. Additional offerings include point-of-care diagnostic solutions like Smart GUARD and MTL for specific clinical applications.

The company’s devices are classified under EU IVD regulations, spanning Class A, B, C, and IVD General categories, and are registered in the EUDAMED database. Appolon Bioteck operates from France, adhering to EU regulatory requirements for in vitro diagnostics.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
France
Address
205, Rue des Frères Lumière, CHAPONNAY, France
Facebook
—
Phone
+33 4 37 57 00 54
PRRC Contact
Elodie Neau
EUDAMED SRN
FR-MF-000022234
FDA FEI Number
—
DUNS Number
—

Catalogue (9)

DeviceModel / ReferenceRegistriesClassStatus
Hlab27guard AB0039
EUDAMED
Class CActive
Mtl MTL02AB69
EUDAMED
Class AActive
ThromboGUARD FII FV AB0023
EUDAMED
Class CActive
Smart GUARD AB0096
EUDAMED
Class AActive
Hlab27guard AB0022
EUDAMED
Class CActive
ABility Smart Extract AB0038
EUDAMED
Class AActive
SARS-CoV-2 RT-qPCR DETECTION KIT KSC2-AB69
EUDAMED
IVD GeneralActive
RespiGUARD4plex AB0024
EUDAMED
Class BActive
ABility Smart Extract AB0030
EUDAMED
Class AActive

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