Russia Roszdravnadzor registration ФСР 2008/03996

"ELF-22S", "ELF-22M", "ELF-22P", "ELF-22P Max", "ELF-32S", "ELF-32M", "ELF-32P", "ELF-32P Max", "ELF-42S", "ELF-42M", "ELF-42P", "ELF-42P Max", "ELF-442S", "ELF-442M", "ELF-44" 42P", "ELF-442P Max", "ELF-441S", "ELF-441M", "ELF-441P", "ELF-441P Max", "ELF-46S", "ELF-46M", "ELF-46P", "ELF-46P Max", "ELF-48S", "ELF-48M", "ELF-48P", "ELF-48P Max" according to TU 9444-007-93307926-2008

RU: Аппараты слуховые электронные цифровые программируемые воздушного звукопроведения заушного типа "ЭЛЬФ-22S", "ЭЛЬФ-22M", "ЭЛЬФ-22P", "ЭЛЬФ-22P Max", "ЭЛЬФ-32S", "ЭЛЬФ-32M", "ЭЛЬФ-32P", "ЭЛЬФ-32P Max", "ЭЛЬФ-42S", "ЭЛЬФ-42M", "ЭЛЬФ-42P", "ЭЛЬФ-42P Max", "ЭЛЬФ-442S", "ЭЛЬФ-442M", "ЭЛЬФ-442P", "ЭЛЬФ-442P Max", "ЭЛЬФ-441S", "ЭЛЬФ-441M", "ЭЛЬФ-441P", "ЭЛЬФ-441P Max", "ЭЛЬФ-46S", "ЭЛЬФ-46M", "ЭЛЬФ-46P", "ЭЛЬФ-46P Max", "ЭЛЬФ-48S", "ЭЛЬФ-48M", "ЭЛЬФ-48P", "ЭЛЬФ-48P Max" по ТУ 9444-007-93307926-2008
Russia flagRussia·228560·LLC ZSA "RITM"·Registered January 12, 2021·Class 2a
Device information
Device Name (English)
"ELF-22S", "ELF-22M", "ELF-22P", "ELF-22P Max", "ELF-32S", "ELF-32M", "ELF-32P", "ELF-32P Max", "ELF-42S", "ELF-42M", "ELF-42P", "ELF-42P Max", "ELF-442S", "ELF-442M", "ELF-44" 42P", "ELF-442P Max", "ELF-441S", "ELF-441M", "ELF-441P", "ELF-441P Max", "ELF-46S", "ELF-46M", "ELF-46P", "ELF-46P Max", "ELF-48S", "ELF-48M", "ELF-48P", "ELF-48P Max" according to TU 9444-007-93307926-2008
Device Name (Russian)
Аппараты слуховые электронные цифровые программируемые воздушного звукопроведения заушного типа "ЭЛЬФ-22S", "ЭЛЬФ-22M", "ЭЛЬФ-22P", "ЭЛЬФ-22P Max", "ЭЛЬФ-32S", "ЭЛЬФ-32M", "ЭЛЬФ-32P", "ЭЛЬФ-32P Max", "ЭЛЬФ-42S", "ЭЛЬФ-42M", "ЭЛЬФ-42P", "ЭЛЬФ-42P Max", "ЭЛЬФ-442S", "ЭЛЬФ-442M", "ЭЛЬФ-442P", "ЭЛЬФ-442P Max", "ЭЛЬФ-441S", "ЭЛЬФ-441M", "ЭЛЬФ-441P", "ЭЛЬФ-441P Max", "ЭЛЬФ-46S", "ЭЛЬФ-46M", "ЭЛЬФ-46P", "ЭЛЬФ-46P Max", "ЭЛЬФ-48S", "ЭЛЬФ-48M", "ЭЛЬФ-48P", "ЭЛЬФ-48P Max" по ТУ 9444-007-93307926-2008
Device Type (English)
N/A
Device Type (Russian)
228560
Risk Class
Class 2a
OKPD Code
26.60.14.120
Registration information
Registry Key
50034.0
Registration Number
ФСР 2008/03996
Registration Date
January 12, 2021
Manufacturer information
Manufacturer Name (English)
LLC ZSA "RITM"
Manufacturer Name (Russian)
ООО ЗСА "РИТМ"
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
LLC ZSA "RITM", Russia, 127540, Moscow, Dubninskaya str., 12A
Legal Address (Russian)
ООО ЗСА "РИТМ", Россия, 127540, Москва, ул. Дубнинская, д. 12А
Manufacturing Address
115162, Россия, Москва, ул. Хавская, д. 18, к. 2, офис 3, помещ. IV, эт. 4
About this record

Access comprehensive regulatory information for "ELF-22S", "ELF-22M", "ELF-22P", "ELF-22P Max", "ELF-32S", "ELF-32M", "ELF-32P", "ELF-32P Max", "ELF-42S", "ELF-42M", "ELF-42P", "ELF-42P Max", "ELF-442S", "ELF-442M", "ELF-44" 42P", "ELF-442P Max", "ELF-441S", "ELF-441M", "ELF-441P", "ELF-441P Max", "ELF-46S", "ELF-46M", "ELF-46P", "ELF-46P Max", "ELF-48S", "ELF-48M", "ELF-48P", "ELF-48P Max" according to TU 9444-007-93307926-2008 in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number ФСР 2008/03996 and manufactured by LLC ZSA "RITM". The device was registered on January 12, 2021.

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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