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Set of control plasmas for the determination of coagulation factors on coagulometers "Technology Solution" (TS-Factor Control) according to TU 21.20.23-122-42349142-2023 Composed of: 1. TS-Factor control H (lyophilically dried control plasma with a normal range of values), per 1 ml - 3 vials. 2. TS-Factor control P (lyophilically dried control plasma with a pathological range of values), per 1 ml - 3 vials. 3. Instructions for use. 4. Passport. - Roszdravnadzor Registration РЗН 2023/21717

Access comprehensive regulatory information for Set of control plasmas for the determination of coagulation factors on coagulometers "Technology Solution" (TS-Factor Control) according to TU 21.20.23-122-42349142-2023 Composed of: 1. TS-Factor control H (lyophilically dried control plasma with a normal range of values), per 1 ml - 3 vials. 2. TS-Factor control P (lyophilically dried control plasma with a pathological range of values), per 1 ml - 3 vials. 3. Instructions for use. 4. 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 2023/21717 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 2023/21717
Set of control plasmas for the determination of coagulation factors on coagulometers "Technology Solution" (TS-Factor Control) according to TU 21.20.23-122-42349142-2023 Composed of: 1. TS-Factor control H (lyophilically dried control plasma with a normal range of values), per 1 ml - 3 vials. 2. TS-Factor control P (lyophilically dried control plasma with a pathological range of values), per 1 ml - 3 vials. 3. Instructions for use. 4. Passport.
Набор контрольных плазм для определения факторов свертывания на коагулометрах "Technology Solution" (TS-Фактор-контроль) по ТУ 21.20.23-122-42349142-2023 в составе: 1. TS-Фактор-контроль Н (лиофильно высушенная контрольная плазма с нормальным диапазоном значений), на 1 мл - 3 фл. 2. TS-Фактор-контроль П (лиофильно высушенная контрольная плазма с патологическим диапазоном значений), на 1 мл - 3 фл. 3. Инструкция по применению. 4. Паспорт.
Roszdravnadzor Registration Number: РЗН 2023/21717
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Device Information
Device Name (English)
Set of control plasmas for the determination of coagulation factors on coagulometers "Technology Solution" (TS-Factor Control) according to TU 21.20.23-122-42349142-2023 Composed of: 1. TS-Factor control H (lyophilically dried control plasma with a normal range of values), per 1 ml - 3 vials. 2. TS-Factor control P (lyophilically dried control plasma with a pathological range of values), per 1 ml - 3 vials. 3. Instructions for use. 4. Passport.
Device Name (Russian)
Набор контрольных плазм для определения факторов свертывания на коагулометрах "Technology Solution" (TS-Фактор-контроль) по ТУ 21.20.23-122-42349142-2023 в составе: 1. TS-Фактор-контроль Н (лиофильно высушенная контрольная плазма с нормальным диапазоном значений), на 1 мл - 3 фл. 2. TS-Фактор-контроль П (лиофильно высушенная контрольная плазма с патологическим диапазоном значений), на 1 мл - 3 фл. 3. Инструкция по применению. 4. Паспорт.
Device Type (English)
N/A
Device Type (Russian)
192540
Risk Class
Class 2a
OKPD Code
21.20.23.110
Registration Information
Registry Key
73806.0
Registration Number
РЗН 2023/21717
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