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Apparatus for local hypothermia "KHOLOD-01" as per GIKS.941519.107 TU As part of -power supply; - thermoelectric device; - nozzle with a working surface diameter of 50 mm; - nozzle with a working surface diameter of 6 mm. - Roszdravnadzor Registration ФСР 2011/12636

Access comprehensive regulatory information for Apparatus for local hypothermia "KHOLOD-01" as per GIKS.941519.107 TU As part of -power supply; - thermoelectric device; - nozzle with a working surface diameter of 50 mm; - nozzle with a working surface diameter of 6 mm. 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 2011/12636 and manufactured by EPZ JSC. The device was registered on February 13, 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
ФСР 2011/12636
Apparatus for local hypothermia "KHOLOD-01" as per GIKS.941519.107 TU As part of -power supply; - thermoelectric device; - nozzle with a working surface diameter of 50 mm; - nozzle with a working surface diameter of 6 mm.
Аппарат для локальной гипотермии "ХОЛОД-01" по ГИКС.941519.107 ТУ в составе - источник питания; - устройство термоэлектрическое; - насадка диаметром рабочей поверхности 50 мм; - насадка с диаметром рабочей поверхности 6 мм.
Roszdravnadzor Registration Number: ФСР 2011/12636
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Device Information
Device Name (English)
Apparatus for local hypothermia "KHOLOD-01" as per GIKS.941519.107 TU As part of -power supply; - thermoelectric device; - nozzle with a working surface diameter of 50 mm; - nozzle with a working surface diameter of 6 mm.
Device Name (Russian)
Аппарат для локальной гипотермии "ХОЛОД-01" по ГИКС.941519.107 ТУ в составе - источник питания; - устройство термоэлектрическое; - насадка диаметром рабочей поверхности 50 мм; - насадка с диаметром рабочей поверхности 6 мм.
Device Type (English)
N/A
Device Type (Russian)
319210
Risk Class
Class 2a
OKPD Code
26.60.13.190
Registration Information
Registry Key
68730.0
Registration Number
ФСР 2011/12636
Registration Date
February 13, 2023
Manufacturer Information
Manufacturer Name (English)
EPZ JSC
Manufacturer Name (Russian)
АО "ЕПЗ"
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
EPZ JSC, 16 Trubezhnaya, Ryazan, Ryazan Region, 390000, Russia
Legal Address (Russian)
АО "ЕПЗ", Россия, 390000, Рязанская область, г. Рязань, ул. Трубежная, д. 16
Manufacturing Address
391351, Россия, Рязанская область, Касимовский район, р. п. Елатьма, ул. Янина, д. 25