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Innovacon InstAlert hCG One Step Pregnancy Test - HSA Registration DE0506909

Access comprehensive regulatory information for Innovacon InstAlert hCG One Step Pregnancy Test in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0506909 and owned by Innovacon Inc.. The device was registered on May 31, 2022.

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 IVD
DE0506909
Innovacon InstAlert hCG One Step Pregnancy Test
HSA Registration Number: DE0506909
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Product Description

A rapid, one step test for the qualitative detection of human chorionic gonadotropin (hCG) in urine. For professional in vitro diagnostic use only.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0506909
Registration Date
May 31, 2022
Retention Due Date
May 30, 2025
Product Owner
Short Name
Innovacon Inc.
Address
9975, Summers Ridge Road,, San Diego CA, 92121,, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model Information
Model Name(s)
InstAlert One Step hCG Pregnancy Test (50 test strips)
Model Identifier(s)
FHC-101