EOF revoked the self-test for the coronavirus from the market and banned its distribution and disposal
Specifically, EOF decided to ban trafficking and disposal as well as withdrawal from the market, for reasons of public health, of the SARS-CoV-2 NASOCHECKcomfort SARS-CoV-2 Antigen-Schnelltest rapid diagnostic test.
Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO LTD (China). Authorized Representative for the EU: LEPU MEDICAL (EUROPE) COOPERATIEF UA (Netherlands).
The decision states:
Taking into consideration:
1. Article 6, par. II, par. 8 of Law 1316/1983 (Government Gazette 3 A ‘) “Establishment, organization and responsibilities of EOF” as replaced by article 25 of Law 3730/2008 (Government Gazette 262 B ‘)
2. Article 3, par. 1c) of Law 1316/1983 (Government Gazette 3 A ‘) “Establishment, organization and responsibilities of EOF”
3. The provisions of the Ministerial Decision ΔΥ8δ / οικ.3607 / 892 / ΦΕΚ Β / 1060 / 10-08-2001 Harmonization of the Greek Legislation with the Directive 98/79 / EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
4. The application No. 41343/2021 of the company A GLYNOS AND SIA EE in the National Register of Medical Technological Products of EOF
5. The 10/12/2021 Recommendation to the President of EOF of the Product Evaluation Directorate / Department of Sanitary Material Evaluation
The Prohibition of Distribution and Disposal and the Revocation from the Market, for reasons of public health protection, of the diagnostic test for rapid detection of the virus SARS-CoV-2, NASOCHECKcomfort SARS-CoV-2 Antigen-Schnelltest (Manufacturer: BEIJINGGPECH M. , LTD, China, Authorized Representative: LEPU MEDICAL (EUROPE) COOPERATIEF UA, The Netherlands), which does not bear the CE Marking in accordance with the provisions of Road 98/79 / EC.
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