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VITROLIFE EMBRYOSCOPE TIME LAPSE SYSTEM - HSA Registration DE0504692

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 DE0504692 and owned by VITROLIFE A/S. The device was registered on July 13, 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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CLASS B
DE0504692
VITROLIFE EMBRYOSCOPE TIME LAPSE SYSTEM
HSA Registration Number: DE0504692
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Product Description

Incubators are intended to provide an environment with controlled temperature and gas concentration (CO2 and optionally O2) for the culture of gametes and/or embryos and to acquire images of these during incubation. Culture dishes are accessories for embryo storage related to the EmbryoScope+ and EmbryoScope 8 incubators. EmbryoViewer software monitors incubation information from all connected EmbryoScope incubators and is intended for displaying, comparing, storing and transferring images generated by the EmbryoScope time-lapse incubators. ES server is intended to store, archive and transfer data. KIDScore tool is a decision support tool that scores embryos according to their statistical viability by applying a number of criteria to the embryos. iDAScore is intended to evaluate early embryo development through acquired embryo time-lapse videos to assist embryo selection.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0504692
Registration Date
July 13, 2020
Change Notification Approval Date
August 29, 2024
Retention Due Date
July 12, 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)
EmbryoScope+ ES-P1 EmbryoScope 8 EmbryoSlide+ Culture Dish EmbyroSlide+ ic8 Dish KIDScore D5 iDAScore Vitrolife Technology Hub ES server EmbryoViewer (including Guided Annotation as an optional feature) KIDScore D3
Model Identifier(s)
16402 16409 16450 16454 16532 16536 16537 16612 16622 FT-KS-D3