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FUJIFILM Irvine Scientific Sperm Washing Medium - HSA Registration DE0504908

Access comprehensive regulatory information for FUJIFILM Irvine Scientific Sperm Washing Medium in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504908 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.

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CLASS D
DE0504908
FUJIFILM Irvine Scientific Sperm Washing Medium
HSA Registration Number: DE0504908
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Product Description

Sperm Washing Medium is intended for use in assisted reproductive procedures which include human gamete and embryo manipulation. These procedures include the use of this medium for sperm washing.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0504908
Registration Date
September 11, 2020
Change Notification Approval Date
October 23, 2024
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)
Sperm Washing Medium Sperm Washing Medium
Model Identifier(s)
9983-100ML 9983-12x12ML