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Schiller CARDIOVIT AT-1 G2 - HSA Registration DE0501489

Access comprehensive regulatory information for Schiller CARDIOVIT AT-1 G2 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501489 and owned by SCHILLER AG. The device was registered on April 09, 2018.

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.

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CLASS B
DE0501489
Schiller CARDIOVIT AT-1 G2
HSA Registration Number: DE0501489
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Product Description

The CARDIOVIT AT-1 G2 is a 12-channel ECG unit for use by qualified medical personnel in healthcare organisations for the cardiological diagnosis of all patients, regardless of gender, ethnicity and age. ECG analysis is complemented with algorithms that provide measurement results, data, graphic presentation and interpretation for review by the user.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0501489
Registration Date
April 09, 2018
Change Notification Approval Date
June 24, 2021
Retention Due Date
April 08, 2026
Product Owner
Short Name
SCHILLER AG
Address
Altgasse 68, Postfach, CH-6341 Baar, SWITZERLAND
Registrant
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model Information
Model Name(s)
CARDIOVIT AT-1 G2 Set of adult ECG electrodes incl. 6 suction Set of children ECG electrodes incl. 6 suction 10-wire patient cable IEC 2m, banana plug type 10-wire patient cable AHA 2m, banana plug type 10-wire patient cable IEC, 3.5m clip-type 10-wire patient cable, clip type, 3.5m, AHA
Model Identifier(s)
0A.107000 2.000041 2.000052 2.400070 2.400071 2.400095 2.400104