Pure Global

Immunochemical analyzer UniCel DxI 800 with accessories Immunochemical analyzer UniCel DxI 800 Access® Immunoassay system Basic composition: 1. Analytical unit UniCel®®® DxI 800. 2. Computer (system unit). 3. A set of accessories for connecting and servicing the analyzer... (see the full description in the card) - Roszdravnadzor Registration РЗН 2015/2862

Access comprehensive regulatory information for Immunochemical analyzer UniCel DxI 800 with accessories Immunochemical analyzer UniCel DxI 800 Access® Immunoassay system Basic composition: 1. Analytical unit UniCel®®® DxI 800. 2. Computer (system unit). 3. A set of accessories for connecting and servicing the analyzer... (see the full description in the card) 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 2015/2862 and manufactured by Beckman Coulter Inc.. The device was registered on July 15, 2015.

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

Free Database
Powered by Pure Global AI
Roszdravnadzor Official Data
Class 2a
РЗН 2015/2862
Immunochemical analyzer UniCel DxI 800 with accessories Immunochemical analyzer UniCel DxI 800 Access® Immunoassay system Basic composition: 1. Analytical unit UniCel®®® DxI 800. 2. Computer (system unit). 3. A set of accessories for connecting and servicing the analyzer... (see the full description in the card)
Анализатор иммунохимический UniCel® DxI 800 с принадлежностями Анализатор иммунохимический UniCel® DxI 800 Access® Immunoassay system Базовый состав: 1. Аналитический блок UniCel® DxI 800. 2. Компьютер (системный блок). 3. Набор принадлежностей для подключения и облуживания анализатора... (см. в карточке полное описание)
Roszdravnadzor Registration Number: РЗН 2015/2862
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Information
Device Name (English)
Immunochemical analyzer UniCel DxI 800 with accessories Immunochemical analyzer UniCel DxI 800 Access® Immunoassay system Basic composition: 1. Analytical unit UniCel®®® DxI 800. 2. Computer (system unit). 3. A set of accessories for connecting and servicing the analyzer... (see the full description in the card)
Device Name (Russian)
Анализатор иммунохимический UniCel® DxI 800 с принадлежностями Анализатор иммунохимический UniCel® DxI 800 Access® Immunoassay system Базовый состав: 1. Аналитический блок UniCel® DxI 800. 2. Компьютер (системный блок). 3. Набор принадлежностей для подключения и облуживания анализатора... (см. в карточке полное описание)
Device Type (English)
N/A
Device Type (Russian)
Unknown
Risk Class
Class 2a
OKPD Code
94 4310
Registration Information
Registry Key
10603
Registration Number
РЗН 2015/2862
Registration Date
July 15, 2015
Validity Period
January 01, 2262
Manufacturer Information
Manufacturer Name (English)
Beckman Coulter Inc.
Manufacturer Name (Russian)
Бекмен Культер Инк.
Country (English)
USA
Country (Russian)
USA
Legal Address (English)
США Дальнее зарубежье Beckman Coulter Inc. 250 S. Kraemer Blvd. Brea CA 92821 USA
Legal Address (Russian)
США Дальнее зарубежье Beckman Coulter Inc. 250 S. Kraemer Blvd. Brea CA 92821 USA
Manufacturing Address
1000 Lake Hazeltine Dr. Chaska MN 55318 USA