Singapore HSA registration DE0504909
FUJIFILM Irvine Scientific Multipurpose Handling Medium with Gentamicin
Singapore·CLASS C·FUJIFILM Irvine Scientific, Inc.·Registered September 11, 2020Device 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 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.
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
About this record
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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