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A set of calibration plasmas for the determination of coagulation factors on coagulometers "Technology Solution" (TS-Factor calibrator) according to TU 21.20.23-121-42349142-2023 Composed of: 1. TS-Factor calibrator (lyophilically dried calibration plasma), 3 vials per 1 ml. 2. Instructions for use. 3. Passport. - Roszdravnadzor Registration РЗН 2023/21715

Access comprehensive regulatory information for A set of calibration plasmas for the determination of coagulation factors on coagulometers "Technology Solution" (TS-Factor calibrator) according to TU 21.20.23-121-42349142-2023 Composed of: 1. TS-Factor calibrator (lyophilically dried calibration plasma), 3 vials per 1 ml. 2. Instructions for use. 3. 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 2023/21715 and manufactured by Technologia-Standard LLC. The device was registered on December 18, 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
РЗН 2023/21715
A set of calibration plasmas for the determination of coagulation factors on coagulometers "Technology Solution" (TS-Factor calibrator) according to TU 21.20.23-121-42349142-2023 Composed of: 1. TS-Factor calibrator (lyophilically dried calibration plasma), 3 vials per 1 ml. 2. Instructions for use. 3. Passport.
Набор калибровочных плазм для определения факторов свертывания на коагулометрах "Technology Solution" (TS-Фактор-калибратор) по ТУ 21.20.23-121-42349142-2023 в составе: 1. TS-Фактор-калибратор (лиофильно высушенная калибровочная плазма), на 1 мл - 3 фл. 2. Инструкция по применению. 3. Паспорт.
Roszdravnadzor Registration Number: РЗН 2023/21715
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Device Information
Device Name (English)
A set of calibration plasmas for the determination of coagulation factors on coagulometers "Technology Solution" (TS-Factor calibrator) according to TU 21.20.23-121-42349142-2023 Composed of: 1. TS-Factor calibrator (lyophilically dried calibration plasma), 3 vials per 1 ml. 2. Instructions for use. 3. Passport.
Device Name (Russian)
Набор калибровочных плазм для определения факторов свертывания на коагулометрах "Technology Solution" (TS-Фактор-калибратор) по ТУ 21.20.23-121-42349142-2023 в составе: 1. TS-Фактор-калибратор (лиофильно высушенная калибровочная плазма), на 1 мл - 3 фл. 2. Инструкция по применению. 3. Паспорт.
Device Type (English)
N/A
Device Type (Russian)
196500
Risk Class
Class 2a
OKPD Code
21.20.23.110
Registration Information
Registry Key
73804.0
Registration Number
РЗН 2023/21715
Registration Date
December 18, 2023
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