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FUJIFILM Irvine Scientific Multipurpose Handling Medium with Gentamicin - HSA Registration DE0504909

Access comprehensive regulatory information for FUJIFILM Irvine Scientific Multipurpose Handling Medium with Gentamicin in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504909 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 C
DE0504909
FUJIFILM Irvine Scientific Multipurpose Handling Medium with Gentamicin
HSA Registration Number: DE0504909
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Product Description

MHM is intended for use in assisted reproductive procedures which involve the manipulation of gametes or embryos. Specifically, MHM is indicated for use as an oocyte retrieval medium during ovarian follicle aspiration procedures (not for flushing ovarian follicles), washing sperm prior to IVF and ICSI fertilization procedures, and for transport of the embryo to the uterus during embryo transfer procedures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0504909
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)
MHM with Gentamicin MHM with Gentamicin
Model Identifier(s)
90163-100ML 90163-500ML