Pure Global AI
EUDAMED registration D-4751020YPYes

HCGSN 230 MR: 64 ch Adult Medium 56-58 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-4751020YP
Basic UDI
B-4751020YP
Version date
July 25, 2022
Manufacturer last update
September 15, 2022
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
Name
MPS Medical Product Service GmbH
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, Czech Republic: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: 64 ch Adult Medium 56-58 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-4751020YP 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.