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EUDAMED registration D-4752001YSYes

HCGSN 230 MR LTM: 128 Channel Adult X-Large 61-64 cm

Magstim Inc.Class IIaEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Z12100303
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
D-4752001YS
Basic UDI
B-4752001YS
Version date
July 25, 2022
Manufacturer last update
January 11, 2023
Active status
Yes
Manufacturer
Manufacturer name
Magstim Inc.
Country
United States
Country type
NON_EU
Address
78 Centennial Loop Eugene
Email
regulatory@magstim.com
Authorized representative
SRN
DE-AR-000005009
Country
Germany
Address
20 Borngasse Braunfels
Email
g.froemel@mps-gmbh.eu
Telephone
+49 6442962073
Regulatory information
Competent authority
DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Germany
Market available
Austria:2017-03-03~2024-05-26, Belgium:2017-03-03~2024-05-26, Bulgaria:2017-03-03~2024-05-26, Croatia:2017-03-03~2024-05-26, Cyprus:2017-03-03~2024-05-26, Czechia:2017-03-03~2024-05-26, Denmark:2017-03-03~2024-05-26, Estonia:2017-03-03~2024-05-26, Finland:2017-03-03~2024-05-26, France:2017-03-03~2024-05-26, Germany:2017-03-03~2024-05-26, Greece:2017-03-03~2024-05-26, Hungary:2017-03-03~2024-05-26, Iceland:2017-03-03~2024-05-26, Ireland:2017-03-03~2024-05-26, Italy:2017-03-03~2024-05-26, Latvia:2017-03-03~2024-05-26, Liechtenstein:2017-03-03~2024-05-26, Lithuania:2017-03-03~2024-05-26, Luxembourg:2017-03-03~2024-05-26, Malta:2017-03-03~2024-05-26, Netherlands:2017-03-03~2024-05-26, Norway:2017-03-03~2024-05-26, Poland:2017-03-03~2024-05-26, Portugal:2017-03-03~2024-05-26, Romania:2017-03-03~2024-05-26, Slovakia:2017-03-03~2024-05-26, Slovenia:2017-03-03~2024-05-26, Spain:2017-03-03~2024-05-26, Sweden:2017-03-03~2024-05-26, Turkey:2017-03-03~2024-05-26, United Kingdom (Northern Ireland only):2017-03-03~2024-05-26
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES

About this record

Access comprehensive regulatory information for HCGSN 230 MR LTM: 128 Channel Adult X-Large 61-64 cm in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI D-4752001YS and manufactured by Magstim Inc. in United States.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I), 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.