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A set of reagents for the enzyme-linked immunosorbent assay of free prostate-specific antigen in serum and plasma (obPSA-ELISA). - Roszdravnadzor Registration ФС 01012006/3558-06

Access comprehensive regulatory information for A set of reagents for the enzyme-linked immunosorbent assay of free prostate-specific antigen in serum and plasma (obPSA-ELISA). in the Russia medical device market through Pure Global AI's free database. This Class 1 medical device is registered under Roszdravnadzor registration number ФС 01012006/3558-06 and manufactured by HEMA-MEDICA LLC. The device was registered on June 27, 2006.

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 1
ФС 01012006/3558-06
A set of reagents for the enzyme-linked immunosorbent assay of free prostate-specific antigen in serum and plasma (obPSA-ELISA).
Набор реагентов для иммуноферментного определения свободного простатаспецифического антигена в сыворотке и плазме крови (обПСА-ИФА).
Roszdravnadzor Registration Number: ФС 01012006/3558-06
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Device Information
Device Name (English)
A set of reagents for the enzyme-linked immunosorbent assay of free prostate-specific antigen in serum and plasma (obPSA-ELISA).
Device Name (Russian)
Набор реагентов для иммуноферментного определения свободного простатаспецифического антигена в сыворотке и плазме крови (обПСА-ИФА).
Device Type (English)
N/A
Device Type (Russian)
Unknown
Risk Class
Class 1
OKPD Code
93 9817
Registration Information
Registry Key
o22777
Registration Number
ФС 01012006/3558-06
Registration Date
June 27, 2006
Validity Period
June 27, 2011
Manufacturer Information
Manufacturer Name (English)
HEMA-MEDICA LLC
Manufacturer Name (Russian)
ООО ХЕМА-МЕДИКА
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
125319, Moscow, 4th street, 8 Marta street, 3, bldg. 3, room 2
Legal Address (Russian)
125319 Москва 4-я ул. 8 Марта д. 3 стр. 3 помещение 2