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Notification report


Full notification file


General information

Notification Number
B/SI/18/01

Member State to which the notification was sent
Slovenia

Date of acknowledgement from the Member State Competent Authority
17/12/2018

Title of the Project
Evaluation of the GluSense Glyde CGM safety and performance in subjects with Type 1 Diabetes Mellitu

Proposed period of release:
01/05/2019 to 31/12/2020

Name of the Institute(s) or Company(ies)
Adax International d.o.o., Bravničarjeva 13, 1000 Ljubljana,
Slovenia;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
Genetically engineered cell line (C710/16) derived from the human retina (Homo
sapiens)


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known