Singapore HSA registration DE0506414
Fujifilm Irvine Scientific HTF Medium (IVF media for Gametes and Embryo)
Singapore·CLASS D·FUJIFILM Irvine Scientific, Inc.·Registered November 26, 2021Device 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 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.
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)
About this record
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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