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Singapore HSA registration DE0508940

Newronika HDCstim System Current Stimulator

Singapore flagSingapore·CLASS B·Newronika S.p.A.·Registered February 07, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0508940
Registration Date
February 07, 2024
Retention Due Date
February 06, 2026
Product description
HDCkit is used for providing Transcranial Direct Current Stimulation to patients in home environment. Depending on the brain area treated, HDCkit System can be used as adjuvant treatment of different conditions. HDCkit System is intended to reduce symptoms related to: ● Chronic pain; ● After stroke rehabilitation: only supports the Physical improvements after stroke rehabilitation; ● Depression”.
Product Owner
Name
Newronika S.p.A.
Short Name
Newronika S.p.A.
Address
via Dante 4, 20121 Milan, ITALY
Registrant
Name
DANMEDIK (S) PRIVATE LIMITED
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Importer
Name
DANMEDIK (S) PRIVATE LIMITED
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Model information
Model Name(s)
Electrode in conductive silicone 50x50 Electrode in conductive silicone 85x60 Spontex 25cm^2 Spontex 35cm^2 Spontex 70cm2 Conductive gel solution HDCel HDCprog HDCstim ISOcable Spontex 50x50 Spontex 85x60
Model Identifier(s)
EF50X50 EF85X60 ELM25 ELM35 ELM70 Gelspk HDCel HDCprog HDCstim ISOcable SPF50X50 SPF85X60
About this record

Access comprehensive regulatory information for Newronika HDCstim System Current Stimulator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508940 and owned by Newronika S.p.A.. The device was registered on February 07, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B