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Vitrolife EmbryoScope Time-lapse System - HSA Registration DE0019298

Access comprehensive regulatory information for Vitrolife EmbryoScope Time-lapse System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019298 and owned by VITROLIFE A/S. The device was registered on June 05, 2017.

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
DE0019298
Vitrolife EmbryoScope Time-lapse System
HSA Registration Number: DE0019298
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Product Description

The intended use of the EmbryoScope incubator is to provide an environment with controlled temperature and gas concentrations (CO2 and optionally O2) for the culture of gametes and/or embryos and to acquire images of these during incubation. The EmbryoSlide culture dish is an accessory for embryo storage related to the EmbryoScope incubator, which provides an environment with controlled temperature and gas concentrations (CO2 and optionally O2) for the development of gametes and/ or embryos at or near body temperature. The EmbryoViewerยฎ software is an accessory to the EmbryoScope time-lapse incubator. The ES server is an information system intended to store, archive and transfer data.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0019298
Registration Date
June 05, 2017
Change Notification Approval Date
August 29, 2024
Retention Due Date
June 04, 2025
Product Owner
Short Name
VITROLIFE A/S
Address
JENS JUULS VEJ 16,, 8260 VIBY J, DENMARK, DENMARK
Registrant
Address
140 PAYA LEBAR ROAD, AZ @ PAYA LEBAR, #09-24, SINGAPORE 409015
Importer
Address
140 PAYA LEBAR ROAD, AZ @ PAYA LEBAR, #09-24, SINGAPORE 409015 15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model Information
Model Name(s)
ES server EmbryoViewer (including Guided Annotation as an optional feature) EmbryoScope ES-D KIDScore D3 EmbryoSlide Culture dish
Model Identifier(s)
16612 16622 ESD20000-EU FT-KS-D3 FT-S-ES-D