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HELIOS 8SP, HELIOS 12NR, HELIOS 12S, HELIOS 20NR, HELIOS 20S Electronic Programmable Auditory Hearing Aids as per TU 9444-032-93307926-2015 with accessories Accessories: 1. Sound conductor No 1 - 1 pc. 2. Sound probe No 2 - 1 pc. 3. Sound pipe No 3 - 1 pc. 4. Case - 1 pc. 5. 1.4V battery: - TYPE 13 (for HELIOS 12NR, HELIOS 12S, HELIOS 20NR), "HELIOS 20S") - 2 pcs.; - TYPE 675 (for "HELIOS 8SP") - 2 pcs. 6. Box - 1 pc. 7. Operation manual - 1 pc. - Roszdravnadzor Registration РЗН 2016/4954

Access comprehensive regulatory information for HELIOS 8SP, HELIOS 12NR, HELIOS 12S, HELIOS 20NR, HELIOS 20S Electronic Programmable Auditory Hearing Aids as per TU 9444-032-93307926-2015 with accessories Accessories: 1. Sound conductor No 1 - 1 pc. 2. Sound probe No 2 - 1 pc. 3. Sound pipe No 3 - 1 pc. 4. Case - 1 pc. 5. 1.4V battery: - TYPE 13 (for HELIOS 12NR, HELIOS 12S, HELIOS 20NR), "HELIOS 20S") - 2 pcs.; - TYPE 675 (for "HELIOS 8SP") - 2 pcs. 6. Box - 1 pc. 7. Operation manual - 1 pc. 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 2016/4954 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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Class 2a
РЗН 2016/4954
HELIOS 8SP, HELIOS 12NR, HELIOS 12S, HELIOS 20NR, HELIOS 20S Electronic Programmable Auditory Hearing Aids as per TU 9444-032-93307926-2015 with accessories Accessories: 1. Sound conductor No 1 - 1 pc. 2. Sound probe No 2 - 1 pc. 3. Sound pipe No 3 - 1 pc. 4. Case - 1 pc. 5. 1.4V battery: - TYPE 13 (for HELIOS 12NR, HELIOS 12S, HELIOS 20NR), "HELIOS 20S") - 2 pcs.; - TYPE 675 (for "HELIOS 8SP") - 2 pcs. 6. Box - 1 pc. 7. Operation manual - 1 pc.
Аппараты слуховые электронные цифровые программируемые воздушного звукопроведения заушного типа "ХЕЛИОС 8SP", "ХЕЛИОС 12НР", "ХЕЛИОС 12S", "ХЕЛИОС 20НР", "ХЕЛИОС 20S" по ТУ 9444-032-93307926-2015 с принадлежностями Принадлежности: 1. Звукопровод № 1 - 1 шт. 2. Звукопровод № 2 - 1 шт. 3. Звукопровод № 3 - 1 шт. 4. Футляр - 1 шт. 5. Элемент питания 1,4 В: - ТИП 13 (для "ХЕЛИОС 12НР", "ХЕЛИОС 12S", "ХЕЛИОС 20НР", "ХЕЛИОС 20S") - 2 шт.; - ТИП 675 (для "ХЕЛИОС 8SP") - 2 шт. 6. Коробка - 1 шт. 7. Руководство по эксплуатации - 1 шт.
Roszdravnadzor Registration Number: РЗН 2016/4954
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Device Information
Device Name (English)
HELIOS 8SP, HELIOS 12NR, HELIOS 12S, HELIOS 20NR, HELIOS 20S Electronic Programmable Auditory Hearing Aids as per TU 9444-032-93307926-2015 with accessories Accessories: 1. Sound conductor No 1 - 1 pc. 2. Sound probe No 2 - 1 pc. 3. Sound pipe No 3 - 1 pc. 4. Case - 1 pc. 5. 1.4V battery: - TYPE 13 (for HELIOS 12NR, HELIOS 12S, HELIOS 20NR), "HELIOS 20S") - 2 pcs.; - TYPE 675 (for "HELIOS 8SP") - 2 pcs. 6. Box - 1 pc. 7. Operation manual - 1 pc.
Device Name (Russian)
Аппараты слуховые электронные цифровые программируемые воздушного звукопроведения заушного типа "ХЕЛИОС 8SP", "ХЕЛИОС 12НР", "ХЕЛИОС 12S", "ХЕЛИОС 20НР", "ХЕЛИОС 20S" по ТУ 9444-032-93307926-2015 с принадлежностями Принадлежности: 1. Звукопровод № 1 - 1 шт. 2. Звукопровод № 2 - 1 шт. 3. Звукопровод № 3 - 1 шт. 4. Футляр - 1 шт. 5. Элемент питания 1,4 В: - ТИП 13 (для "ХЕЛИОС 12НР", "ХЕЛИОС 12S", "ХЕЛИОС 20НР", "ХЕЛИОС 20S") - 2 шт.; - ТИП 675 (для "ХЕЛИОС 8SP") - 2 шт. 6. Коробка - 1 шт. 7. Руководство по эксплуатации - 1 шт.
Device Type (English)
N/A
Device Type (Russian)
228560
Risk Class
Class 2a
OKPD Code
26.60.14.120
Registration Information
Registry Key
50017.0
Registration Number
РЗН 2016/4954
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