Pure Global

FUJIFILM Irvine Scientific ISolate Sperm Separation Medium - HSA Registration DE0504911

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0504911
FUJIFILM Irvine Scientific ISolate Sperm Separation Medium
HSA Registration Number: DE0504911
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

ISolateยฎ 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.

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 Owner
Short Name
FUJIFILM Irvine Scientific, Inc.
Address
2511 Daimler Street, Santa Ana, California 92705, UNITED STATES
Registrant
Address
1 BUKIT BATOK CRESCENT, WCEGA PLAZA, #03-13/14, SINGAPORE 658064
Importer
Address
1 BUKIT BATOK CRESCENT, WCEGA PLAZA, #03-13/14, SINGAPORE 658064
Model Information
Model Name(s)
ISolateยฎ ISolateยฎ ISolateยฎ ISolateยฎ Stock solution ISolateยฎ concentrate
Model Identifier(s)
99264-12x6ML 99264-2x100ML 99264-2x50ML 99275 99306