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Mobidiag Ltd.

Finland·FI-MF-000001215

Last updated September 18, 2026

What Mobidiag Ltd. makes

Mobidiag Ltd. manufactures in vitro diagnostic (IVD) kits and calibration tools for microbiological testing, including molecular and immunological assays. Their products detect pathogens such as *Clostridium difficile*, parasites, and respiratory pathogens, alongside calibration standards for analyzer performance. The portfolio also includes automated analyzers and process control solutions for laboratory workflows.

The company’s devices fall under EU IVD Class A and IVD General categories, with relevant products registered in the EU’s eudamed database. Mobidiag Ltd. is based in Finland and adheres 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
Finland
Address
16 A, Keilaranta 16 A, Espoo, Finland
LinkedIn
—
Facebook
—
Phone
+358 10 5050 770
PRRC Contact
Timo Soininen
EUDAMED SRN
FI-MF-000001215
FDA FEI Number
—
DUNS Number
—

Catalogue (33)

DeviceModel / ReferenceRegistriesClassStatus
Amplidiag C. difficile+027 Kit AD-CD-300
EUDAMED
IVD GeneralActive
Amplidiag COVID-19 Calibration Kit AD-CVCS-30
EUDAMED
IVD GeneralActive
Amplidiag RESP-4 Calibration Kit AD-RP4CS-30
EUDAMED
IVD GeneralActive
Amplidiag Analyzer AD-ASW
EUDAMED
IVD GeneralActive
Novodiag C. difficile NVD-CD-012
EUDAMED
IVD GeneralActive
Amplidiag Easy Process Control II AE-RC803x8
EUDAMED
IVD GeneralActive
Amplidiag Bacterial GE Kit AD-BGE-100
EUDAMED
IVD GeneralActive
Novodiag Stool Parasites NVD-SP-010
EUDAMED
IVD GeneralActive
mNAT S Medium MD-NATS-50
EUDAMED
Class AActive
Amplidiag Stool Parasites Kit AD-SP-100
EUDAMED
IVD GeneralActive
Amplidiag CarbaR Calibration Kit AD-CPCS-30
EUDAMED
IVD GeneralActive
Amplidiag Bacterial GE Calibration Kit AD-BGECS-30
EUDAMED
IVD GeneralActive
Amplidiag Stool Parasites Calibration Kit AD-SPCS-30
EUDAMED
IVD GeneralActive
Amplidiag Easy Extraction Kit I AE-EXT-016
EUDAMED
Class AActive
Amplidiag C. difficile+027 Calibration Kit AD-CDCS-30
EUDAMED
IVD GeneralActive
Novodiag Bacterial GE+ NVD-BGE-012
EUDAMED
IVD GeneralActive
Amplidiag Viral GE Kit AD-VGE-100
EUDAMED
IVD GeneralActive
Amplidiag Easy Process Control I AE-RC802x8
EUDAMED
IVD GeneralActive
Novodiag CarbaR+ NVD-CRB-012
EUDAMED
IVD GeneralActive
Amplidiag CarbaR+ MCR Kit AD-CPM-100
EUDAMED
IVD GeneralActive
mNAT V Medium MD-NATV-50
EUDAMED
Class AActive
mNAT R Medium MD-NATR-50
EUDAMED
Class AActive
mNAT Medium MD-NAT-50
EUDAMED
Class AActive
Amplidiag H. pylori+ClariR Kit AD-HP-80
EUDAMED
IVD GeneralActive
Amplidiag RESP-4 Kit AD-RP4-864
EUDAMED
IVD GeneralActive
Amplidiag CarbaR+ VRE Kit AD-CP-100
EUDAMED
IVD GeneralActive
Novodiag Instrument NVD-INST-B
EUDAMED
Class AActive
Amplidiag COVID-19 Kit AD-CV-864
EUDAMED
IVD GeneralActive
Novodiag RESP-4 Novodiag RESP-4
EUDAMED
IVD GeneralActive
Amplidiag H. pylori+ClariR Calibration Kit AD-HPCS-30
EUDAMED
IVD GeneralActive
Novodiag Instrument Rev. B Package NVD-INST-B-K
EUDAMED
Class AActive
Novodiag COVID-19 NVD-CV-012
EUDAMED
IVD GeneralActive
Amplidiag Viral GE Calibration Kit AD-VGECS-30
EUDAMED
IVD GeneralActive

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