Russia Roszdravnadzor registration ФСЗ 2008/00053

Urine screening test strips1. Test strips Combur 10 Test M.2. Calibration test strips Control-Test M.

RU: Тест-полоски для скринингового анализа мочи1. Тест-полоски Combur 10 Test М.2. Тест-полоски калибровочные Control-Test М.
Russia flagRussia·Multiple Analytes Clinical Chemistry IVD Calibrator;Multiple Urine Analytes IVD Kit Colorimetric Express Analysis Clinical·Roche Diagnostics GmbH·Registered August 08, 2022·Class 1
Device information
Device Name (English)
Urine screening test strips1. Test strips Combur 10 Test M.2. Calibration test strips Control-Test M.
Device Name (Russian)
Тест-полоски для скринингового анализа мочи1. Тест-полоски Combur 10 Test М.2. Тест-полоски калибровочные Control-Test М.
Device Type (English)
Multiple Analytes Clinical Chemistry IVD Calibrator;Multiple Urine Analytes IVD Kit Colorimetric Express Analysis Clinical
Device Type (Russian)
Множественные аналиты клинической химии ИВД калибратор;Множественные аналиты мочи ИВД набор колориметрический экспресс-анализ клинический
Risk Class
Class 1
OKPD Code
21.20.23.110
Registration information
Registry Key
64787
Registration Number
ФСЗ 2008/00053
Registration Date
August 08, 2022
Validity Period
January 01, 2262
Manufacturer information
Manufacturer Name (English)
Roche Diagnostics GmbH
Manufacturer Name (Russian)
Рош Диагностикс ГмбХ
Country (English)
Germany
Country (Russian)
Germany
Legal Address (English)
Германия Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany
Legal Address (Russian)
Германия Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany
Manufacturing Address
Roche Diagnostics GmbH Centralised and Point of Care Solutions Sandhofer Strasse 116 68305 Mannheim Germany
About this record

Access comprehensive regulatory information for Urine screening test strips1. Test strips Combur 10 Test M.2. Calibration test strips Control-Test M. in the Russia medical device market through Pure Global AI's free database. This Class 1 medical device is registered under Roszdravnadzor registration number ФСЗ 2008/00053 and manufactured by Roche Diagnostics GmbH. The device was registered on August 08, 2022.

This page provides complete registration details including device type, manufacturer information, country of origin (Germany), 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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