Pure Global

Reagent kit for immunochromatographic detection of antibodies to hepatitis C virus (HCV) in blood serum (plasma) (ImmunoChromium-antiHCV-Express) according to TU 9398-303-53915567-02 - Roszdravnadzor Registration ФСР 2008/03734

Access comprehensive regulatory information for Reagent kit for immunochromatographic detection of antibodies to hepatitis C virus (HCV) in blood serum (plasma) (ImmunoChromium-antiHCV-Express) according to TU 9398-303-53915567-02 in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number ФСР 2008/03734 and manufactured by LLC "MED-EXPRESS-DIAGNOSTICS". The device was registered on June 20, 2022.

This page provides complete registration details including device type, manufacturer information, country of origin (Russia), and regulatory compliance data from the official Russia Roszdravnadzor medical device database. Pure Global AI offers free access to Russia's complete medical device registry, helping global MedTech companies navigate Roszdravnadzor regulations efficiently.

Free Database
Powered by Pure Global AI
Roszdravnadzor Official Data
Class 2b
ФСР 2008/03734
Reagent kit for immunochromatographic detection of antibodies to hepatitis C virus (HCV) in blood serum (plasma) (ImmunoChromium-antiHCV-Express) according to TU 9398-303-53915567-02
Набор реагентов для иммунохроматографического выявления антител к вирусу гепатита С (ВГС) в сыворотке (плазме) крови (ИммуноХром-антиВГС-Экспресс) по ТУ 9398-303-53915567-02
Roszdravnadzor Registration Number: ФСР 2008/03734
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Information
Device Name (English)
Reagent kit for immunochromatographic detection of antibodies to hepatitis C virus (HCV) in blood serum (plasma) (ImmunoChromium-antiHCV-Express) according to TU 9398-303-53915567-02
Device Name (Russian)
Набор реагентов для иммунохроматографического выявления антител к вирусу гепатита С (ВГС) в сыворотке (плазме) крови (ИммуноХром-антиВГС-Экспресс) по ТУ 9398-303-53915567-02
Device Type (English)
N/A
Device Type (Russian)
287370
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
64686.0
Registration Number
ФСР 2008/03734
Registration Date
June 20, 2022
Manufacturer Information
Manufacturer Name (English)
LLC "MED-EXPRESS-DIAGNOSTICS"
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
LLC "MED-EXPRESS-DIAGNOSTICS", Russia, 109651, Moscow, Pererva str., 11, bldg. 20, room. 20P, 22P, 24P
Legal Address (Russian)
ООО "МЕД-ЭКСПРЕСС-ДИАГНОСТИКА", Россия, 109651, Москва, ул. Перерва, д. 11, стр. 20, помещ. 20П, 22П, 24П
Manufacturing Address
143306, Россия, Московская область, г. Наро-Фоминск, ул. Карла Маркса, д. 1, каб. 52