Pure Global

Anesthesia System - EUDAMED Registration 00195278891181

Access comprehensive regulatory information for Anesthesia System in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 00195278891181 and manufactured by Datex-Ohmeda Inc. in United States.

This page provides complete registration details including trade name (CS600 V1 to V2 Upgrade KO ), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class IIb
00195278891181
Yes
Anesthesia System
Trade Name: CS600 V1 to V2 Upgrade KO
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

ANAESTHESIA DEVICES

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z1203010101
Trade Name
CS600 V1 to V2 Upgrade KO
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00195278891181
Basic UDI
8406821BUG00403H6
Version Date
August 19, 2024
Manufacturer Last Update
July 20, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
Datex-Ohmeda Inc.
Country
United States
Country Type
NON_EU
Address
3030 Ohmeda Drive 7550 Madison
Email
jim.raskob@med.ge.com
Authorized Representative
SRN
FR-AR-000000344
Country
France
Address
283 Rue de la Miniere BUC
Email
CoE.Postmarket@ge.com
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Device Characteristics
Human Tissues
No
Animal Tissues
No