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Fujifilm Irvine Scientific PVP Solution (IVF media for Sperm) - HSA Registration DE0506415

Access comprehensive regulatory information for Fujifilm Irvine Scientific PVP Solution (IVF media for Sperm) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506415 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
DE0506415
Fujifilm Irvine Scientific PVP Solution (IVF media for Sperm)
HSA Registration Number: DE0506415
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Product Description

7% PVP Solution with HSA and 10% PVP Solution with HSA are intended for immobilizing sperm for ICSI procedures.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0506415
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)
7% PVP Solution with HSA (5mg/mL) 10% PVP Solution with HSA (5mg/mL)
Model Identifier(s)
90121 90123