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GOTOP RigiScan Plus - HSA Registration DE0509020

Access comprehensive regulatory information for GOTOP RigiScan Plus in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509020 and owned by GOTOP Medical, Inc.. The device was registered on March 02, 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.

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CLASS B
DE0509020
GOTOP RigiScan Plus
HSA Registration Number: DE0509020
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Product Description

The RigiScan Plus System allows you to measure the duration, frequency, and degree of rigidity and tumescence of the penis. The system is suitable for nocturnal data collection or data collection during various provocative interventions that are intended to produce an erectile response. Testing may be conducted in a stand-alone Ambulatory mode or in a Real-time monitoring mode when connected to your computer.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509020
Registration Date
March 02, 2024
Retention Due Date
March 01, 2026
Product Owner
Short Name
GOTOP Medical, Inc.
Address
1000 Westgate Drive, Suite 125, St.Paul, MN 55114, UNITED STATES
Registrant
Address
2 ANG MO KIO STREET 64, ECON INDUSTRIAL BUILDING, #04-03C, SINGAPORE 569084
Importer
Address
40 JALAN PEMIMPIN, TAT ANN BUILDING, #03-01C, SINGAPORE 577185
Model Information
Model Name(s)
RigiScan Plus
Model Identifier(s)
9001