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Hemostasis reagent (Fibrin monomer) as per TU 21.20.23-126-42349142-2023 , version: - Fibrin-monomer (freeze-dried), per 2 ml - 15 vials. The delivery set includes: reagent, instructions for use, passport. - Roszdravnadzor Registration РЗН 2024/22264

Access comprehensive regulatory information for Hemostasis reagent (Fibrin monomer) as per TU 21.20.23-126-42349142-2023 , version: - Fibrin-monomer (freeze-dried), per 2 ml - 15 vials. The delivery set includes: reagent, instructions for use, passport. in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number РЗН 2024/22264 and manufactured by Technologia-Standard LLC. The device was registered on March 26, 2024.

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
РЗН 2024/22264
Hemostasis reagent (Fibrin monomer) as per TU 21.20.23-126-42349142-2023 , version: - Fibrin-monomer (freeze-dried), per 2 ml - 15 vials. The delivery set includes: reagent, instructions for use, passport.
Реагент для исследования гемостаза (Фибрин-мономер) по ТУ 21.20.23-126-42349142-2023 , вариант исполнения: - Фибрин-мономер (лиофильно высушенный), на 2 мл - 15 фл. В комплект поставки входят: реагент, инструкция по применению, паспорт.
Roszdravnadzor Registration Number: РЗН 2024/22264
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Device Information
Device Name (English)
Hemostasis reagent (Fibrin monomer) as per TU 21.20.23-126-42349142-2023 , version: - Fibrin-monomer (freeze-dried), per 2 ml - 15 vials. The delivery set includes: reagent, instructions for use, passport.
Device Name (Russian)
Реагент для исследования гемостаза (Фибрин-мономер) по ТУ 21.20.23-126-42349142-2023 , вариант исполнения: - Фибрин-мономер (лиофильно высушенный), на 2 мл - 15 фл. В комплект поставки входят: реагент, инструкция по применению, паспорт.
Device Type (English)
N/A
Device Type (Russian)
196510
Risk Class
Class 2a
OKPD Code
21.20.23.110
Registration Information
Registry Key
78110.0
Registration Number
РЗН 2024/22264
Registration Date
March 26, 2024
Manufacturer Information
Manufacturer Name (English)
Technologia-Standard LLC
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
Technologia-Standard LLC, 116/95 Kalinina Ave., Barnaul, Altai Territory, 656037, Russia
Legal Address (Russian)
ООО фирма "Технология-Стандарт", Россия, 656037, Алтайский край, г. Барнаул, пр-кт Калинина, д. 116/95
Manufacturing Address
656037, Россия, Алтайский край, г. Барнаул, пр-кт Калинина, д. 116/95