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FUJIFILM Irvine Scientific Modified Ham's F10 - HSA Registration DE0504910

Access comprehensive regulatory information for FUJIFILM Irvine Scientific Modified Ham's F10 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504910 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
DE0504910
FUJIFILM Irvine Scientific Modified Ham's F10
HSA Registration Number: DE0504910
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Product Description

Modified Hamโ€™s F-10 Basal Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of complete Modified Hamโ€™s F-10 as a culture medium through day 3 of development. Modified Hamโ€™s F-10 Basal Medium - HEPES is intended for use in assisted reproductive procedures which include retrieval, handling and transfer of gametes and embryos.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0504910
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)
Modified Ham's F10 Basal Medium, HEPES
Model Identifier(s)
99168