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Singapore HSA registration DE0504911

FUJIFILM Irvine Scientific ISolate Sperm Separation Medium

Singapore flagSingapore·CLASS C·FUJIFILM Irvine Scientific, Inc.·Registered September 11, 2020
Device classification
Device Class
CLASS C
Medical Speciality Area
Obstetrics & Gynaecology
Registration information
Registration Number
DE0504911
Registration Date
September 11, 2020
Change Notification Approval Date
October 22, 2021
Retention Due Date
September 10, 2025
Product description
ISolate® is a density gradient medium designed to separate the motile fraction of sperm from seminal fluid. As a two layer gradient system, it effectively reduces cellular contaminants such as dead sperm, white blood cells and miscellaneous debris. The resulting sample contains predominantly motile sperm.
Product Owner
Name
FUJIFILM Irvine Scientific, Inc.
Short Name
FUJIFILM Irvine Scientific, Inc.
Address
2511 Daimler Street, Santa Ana, California 92705, UNITED STATES
Registrant
Name
LabIVF Asia Pte Ltd.
Address
1 BUKIT BATOK CRESCENT, WCEGA PLAZA, #03-13/14, SINGAPORE 658064
Importer
Name
LABIVF ASIA PTE LTD.
Address
1 BUKIT BATOK CRESCENT, WCEGA PLAZA, #03-13/14, SINGAPORE 658064
Model information
Model Name(s)
ISolate® ISolate® ISolate® ISolate® Stock solution ISolate® concentrate
Model Identifier(s)
99264-12x6ML 99264-2x100ML 99264-2x50ML 99275 99306
About this record

Access comprehensive regulatory information for FUJIFILM Irvine Scientific ISolate Sperm Separation Medium in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504911 and owned by FUJIFILM Irvine Scientific, Inc.. The device was registered on September 11, 2020.

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 C