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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 - Roszdravnadzor Registration ФСР 2008/03661

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.

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Class 2b
ФСР 2008/03661
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
Полоска для иммунохроматографического выявления поверхностного антигена вируса гепатита В (НВsAg) в сыворотке и плазме крови (ИммуноХром-НВsAg-Экспресс) по ТУ 9398-397-53915567-01
Roszdravnadzor Registration Number: ФСР 2008/03661
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Device Information
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
Registration Information
Registry Key
64682.0
Registration Number
ФСР 2008/03661
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