165 devices listed in the TÜV Rheinland Notified Body confirmation letter; IVDR transition pathway confirmed
On 10 July 2026, the EU Notified Body TÜV Rheinland LGA Products GmbH (NB 0197) issued a Notified Body Confirmation Letter stating that the manufacturer Kangsheng Information Technology (Hangzhou) Co., Ltd. (EUDAMED SRN: CN-MF-000053775) has submitted a formal IVDR application for the relevant devices and signed a written agreement with the Notified Body.
Key points of the confirmation letter
- 165 devices are listed in Table 2 of the letter, covering pathogen nucleic acid detection (45 non-fluorescent and 45 fluorescent) and lateral-flow/rapid testing (75 devices);
- By IVDR risk classification: 88 Class C devices and 77 Class B devices;
- A transition pathway applies under Regulation (EU) 2024/1860 (amending the transitional provisions of IVDR (EU) 2017/746): Class C devices transition until 2028-12-31 and Class B devices until 2029-12-31;
- Continued satisfaction of the other conditions of the transitional provisions (including EUDAMED device registration, UDI assignment and a quality management system) is a precondition for applicability.
Regulatory wording note
This status means the devices are listed in a Notified Body confirmation letter; it is not an IVDR certificate, nor a CE certificate. Product names follow the letter's original English wording; specific performance data and intended use are subject to each product's instructions for use (IFU). The complete device list with per-device IVDR classification is available on the product portfolio page.
We will continue to advance our IVDR registration work in line with the transitional provisions and will keep partners informed. For details on the EU regulatory pathway, please contact us.