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Reagent kit for quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human blood serum by enzyme-linked immunosorbent assay (ELISA-DHEA-S) according to TU 9398-105-17253567-2007 - Roszdravnadzor Registration ФСР 2008/02866

Access comprehensive regulatory information for Reagent kit for quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human blood serum by enzyme-linked immunosorbent assay (ELISA-DHEA-S) according to TU 9398-105-17253567-2007 in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number ФСР 2008/02866 and manufactured by LLC NPF "Litekh". The device was registered on December 25, 2023.

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 2a
ФСР 2008/02866
Reagent kit for quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human blood serum by enzyme-linked immunosorbent assay (ELISA-DHEA-S) according to TU 9398-105-17253567-2007
Набор реагентов для количественного определения дегидроэпиандростерон-сульфата (ДГЭА-С) в сыворотке крови человека методом иммуноферментного анализа (ИФА-ДГЭА-С) по ТУ 9398-105-17253567-2007
Roszdravnadzor Registration Number: ФСР 2008/02866
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Device Information
Device Name (English)
Reagent kit for quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human blood serum by enzyme-linked immunosorbent assay (ELISA-DHEA-S) according to TU 9398-105-17253567-2007
Device Name (Russian)
Набор реагентов для количественного определения дегидроэпиандростерон-сульфата (ДГЭА-С) в сыворотке крови человека методом иммуноферментного анализа (ИФА-ДГЭА-С) по ТУ 9398-105-17253567-2007
Device Type (English)
N/A
Device Type (Russian)
см. приложение
Risk Class
Class 2a
OKPD Code
21.20.23.110
Registration Information
Registry Key
75863.0
Registration Number
ФСР 2008/02866
Registration Date
December 25, 2023
Manufacturer Information
Manufacturer Name (English)
LLC NPF "Litekh"
Manufacturer Name (Russian)
ООО НПФ "Литех"
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
NPF Litech LLC, 11 Pererva str., bldg. 29, Moscow, 109651, Russia
Legal Address (Russian)
ООО НПФ "Литех", Россия, 109651, г. Москва, ул. Перерва, д. 11, стр. 29
Manufacturing Address
119435, Россия, Москва, ул. Малая Пироговская, д. 1, стр. 3