Singapore HSA registration DE0504692
VITROLIFE EMBRYOSCOPE TIME LAPSE SYSTEM
Singapore·CLASS B·VITROLIFE A/S·Registered July 13, 2020Device 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 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.
Product Owner
- Name
- VITROLIFE A/S
- 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
About this record
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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