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Origio EmbryoGen®/BlastGen™ (IVF Media for Embryo) - HSA Registration DE0507879

Access comprehensive regulatory information for Origio EmbryoGen®/BlastGen™ (IVF Media for Embryo) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507879 and owned by ORIGIO A/S. The device was registered on March 10, 2023.

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 D
DE0507879
Origio EmbryoGen®/BlastGen™ (IVF Media for Embryo)
HSA Registration Number: DE0507879
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Product Description

EmbryoGen® is for the culture of human embryos until the 2-8 cell stage. EmbryoGen can also be used for embryo transfer on Day 2 or Day 3. BlastGen™ is for the culture of 4-8 cell stage human embryos to the blastocyst stage. BlastGen™ may also be used for embryo transfer.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0507879
Registration Date
March 10, 2023
Retention Due Date
March 09, 2026
Product Owner
Short Name
ORIGIO A/S
Address
Knardrupvej 2, 2760 Måløv, DENMARK
Registrant
Address
1 TEMASEK AVENUE, MILLENIA TOWER, #39-01, SINGAPORE 039192
Importer
Address
1003 BUKIT MERAH CENTRAL, #02-11, SINGAPORE 159836
Model Information
Model Name(s)
EmbryoGen BlastGen EmbryoGen/BlastGen - System pack
Model Identifier(s)
12040003A 12050003A 12062003A