Singapore HSA registration DE0019298
Vitrolife EmbryoScope Time-lapse System
Singapore·CLASS B·VITROLIFE A/S·Registered June 05, 2017Device 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 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 EmbryoViewer® software is an accessory to the EmbryoScope time-lapse incubator. The ES server is an information system intended to store, archive and transfer data.
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)
- 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
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 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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