Product Portfolio
Our portfolio covers 165 devices across 14 clinical series: pathogen nucleic acid detection (non-fluorescent and fluorescent formats) and rapid lateral flow immunoassay. All devices are listed in the Notified Body confirmation letter issued by TÜV Rheinland LGA Products GmbH (NB 0197) on 2026-07-10 under Regulation (EU) 2024/1860.
EU regulatory status of these devices
165 devices listed in the Notified Body confirmation letter (TÜV Rheinland, NB 0197) under Regulation (EU) 2024/1860 — 88 Class C devices with transition to 2028-12-31 and 77 Class B devices with transition to 2029-12-31, subject to the conditions of that Regulation.
The confirmation letter records the IVDR application and the signed written agreement and sets out the transitional arrangements. It is not an IVDR certificate, a CE certificate or an EU Declaration of Conformity, and it does not exempt any device from the remaining conformity assessment steps. We do not describe these devices as "CE-marked", "CE certified" or "CE IVD registered".
Browse by market series
| Market series | Devices | Method | Details |
|---|---|---|---|
| Pathogen nucleic acid detection (non-fluorescent 45 + fluorescent 45) | 90 | Nucleic acid detection / fluorescent PCR | View list |
| Maternal & Women's Health | 5 | Lateral flow immunoassay | View list |
| Hepatitis | 2 | Lateral flow immunoassay | View list |
| Transfusion-transmitted infections | 1 | Lateral flow immunoassay | View list |
| Sexually transmitted infections | 6 | Lateral flow immunoassay | View list |
| Tropical diseases | 7 | Lateral flow immunoassay | View list |
| Gastrointestinal diseases | 10 | Lateral flow immunoassay | View list |
| Respiratory diseases | 8 | Lateral flow immunoassay | View list |
| Tumour markers | 3 | Lateral flow immunoassay | View list |
| Inflammation markers | 7 | Lateral flow immunoassay | View list |
| Cardiac markers | 5 | Lateral flow immunoassay | View list |
| Coagulation | 6 | Lateral flow immunoassay | View list |
| Drug of abuse screening | 9 | Lateral flow immunoassay | View list |
| Other tests | 6 | Lateral flow immunoassay | View list |
| Total | 165 | as listed in the Notified Body confirmation letter, Table 2 | |
The market-series grouping is a commercial classification used for navigation. It is not a legal designation and does not replace the IVDR risk classification of each device, which is shown per device on the series pages.
Documentation and intended use
Each series page lists the devices by the names used in the Notified Body confirmation letter, together with their Basic UDI-DI and IVDR risk class. Intended use, sample types, performance characteristics and specifications are as stated in the Instructions for Use (IFU) and the applicable conformity documentation for each device.
For conformity documentation, IFU or technical documentation requests, please contact us through the inquiry form. Releases are subject to a documentation request review by our regulatory and quality team.
For professional in-vitro diagnostic use only. Products are subject to regulatory approval and registration requirements in each market; availability, packaging configuration and lead times vary by country and are confirmed in the sales contract.
The content of this website is provided for corporate and product information purposes only. It does not constitute an offer, quotation, warranty or medical advice. The terms of the executed sales contract shall prevail.