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ZyMot Sperm Separation Device Multi - HSA Registration DE0510042

Access comprehensive regulatory information for ZyMot Sperm Separation Device Multi in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510042 and owned by ZyMลt Fertility Inc.. The device was registered on November 13, 2024.

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 B
DE0510042
ZyMot Sperm Separation Device Multi
HSA Registration Number: DE0510042
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Product Description

The ZyMลt Multi Sperm Separation Devices are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510042
Registration Date
November 13, 2024
Retention Due Date
November 12, 2025
Product Owner
Short Name
ZyMลt Fertility Inc.
Address
401 Professional Drive,, Suite 130, Gaithersburg, MD, 20879,, UNITED STATES
Registrant
Address
1 TEMASEK AVENUE, MILLENIA TOWER, #39-01, SINGAPORE 039192
Importer
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model Information
Model Name(s)
Sperm Separation Device Multi (850ฮผL) Sperm Separation Device Multi (3mL)
Model Identifier(s)
ZMH0850 ZMH3000