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Singapore HSA registration DE0501593

Schiller SEMA3 Rescue, ECG, and Spiro Management and Analysis Program

Singapore flagSingapore·CLASS B·SCHILLER AG·Registered May 02, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0501593
Registration Date
May 02, 2018
Retention Due Date
May 01, 2026
Product description
SEMA3 is used for the analysis and evaluation of ECG, spiro and rescue data. Other types of recordings can also be referenced in the database for viewing without editing functions or opened and edited with an external program. The following recordings can be analysed: –Resting ECG –Resting Rhythm ECG –Exercise ECG –Signal-averaged ECG –Spirometry –Rescue Data •In addition, the following recordings can be referenced and viewed in PDF format or opened and analysed with an external program: –Ergo-spirometry –Ambulatory Blood Pressure –Holter ECG
Product Owner
Name
SCHILLER AG
Short Name
SCHILLER AG
Address
Altgasse 68, Postfach, CH-6341 Baar, SWITZERLAND
Registrant
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model information
Model Name(s)
SEMA 3
Model Identifier(s)
0A.602000
About this record

Access comprehensive regulatory information for Schiller SEMA3 Rescue, ECG, and Spiro Management and Analysis Program in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501593 and owned by SCHILLER AG. The device was registered on May 02, 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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