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Fujifilm Irvine Scientific HTF Medium (IVF media for Gametes and Embryo) - HSA Registration DE0506414

Access comprehensive regulatory information for Fujifilm Irvine Scientific HTF Medium (IVF media for Gametes and Embryo) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506414 and owned by FUJIFILM Irvine Scientific, Inc.. The device was registered on November 26, 2021.

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
DE0506414
Fujifilm Irvine Scientific HTF Medium (IVF media for Gametes and Embryo)
HSA Registration Number: DE0506414
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Product Description

Human Tubal Fluid (HTF) is intended for use in assisted reproductive procedures which include human gamete and embryo manipulation. These procedures include the use of HTF as a culture medium through day 3 of development. Modified HTF (mHTF) is intended for use in assisted reproductive procedures which include retrieval, handling, and transfer of human gametes and embryos.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0506414
Registration Date
November 26, 2021
Retention Due Date
November 25, 2025
Product Owner
Short Name
FUJIFILM Irvine Scientific, Inc.
Address
1830 E. Warner Ave., Santa Ana, CA 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)
HTF Medium Human Tubal Fluid with: Gentamicin HTF Medium Human Tubal Fluid with: Gentamicin Modified HTF Medium Human Tubal Fluid HEPES Buffered With Gentamicin Modified HTF Medium Human Tubal Fluid HEPES Buffered With Gentamicin
Model Identifier(s)
90125(100ml) 90125(500ml) 90126(100ml) 90126(500ml)