Strip for immunochromatographic detection of hepatitis B virus surface antigen (HBsAg) in blood serum and plasma (ImmunoChrom-HBsAg-Express) according to TU 9398-397-53915567-01
Russia·285680·LLC "MED-EXPRESS-DIAGNOSTICS"·Registered June 20, 2022·Class 2b- Device Name (English)
- Strip for immunochromatographic detection of hepatitis B virus surface antigen (HBsAg) in blood serum and plasma (ImmunoChrom-HBsAg-Express) according to TU 9398-397-53915567-01
- Device Name (Russian)
- Полоска для иммунохроматографического выявления поверхностного антигена вируса гепатита В (НВsAg) в сыворотке и плазме крови (ИммуноХром-НВsAg-Экспресс) по ТУ 9398-397-53915567-01
- Device Type (English)
- N/A
- Device Type (Russian)
- 285680
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 64682.0
- Registration Number
- ФСР 2008/03661
- Registration Date
- June 20, 2022
- Manufacturer Name (English)
- LLC "MED-EXPRESS-DIAGNOSTICS"
- Manufacturer Name (Russian)
- ООО "МЕД-ЭКСПРЕСС-ДИАГНОСТИКА"
- 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
Access comprehensive regulatory information for Strip for immunochromatographic detection of hepatitis B virus surface antigen (HBsAg) in blood serum and plasma (ImmunoChrom-HBsAg-Express) according to TU 9398-397-53915567-01 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 2008/03661 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.