Küsimused

Dear Goda Grybauskaitė,

Thank you for your enquiry.

Indeed, the Medical Devices and Appliances Database (EMDDB) is the database where it is possible to notify us about the distribution of medical devices as required by §26 (4) of the Medical Devices Act.

For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact persons full name and e-mail. 

Please note that accounts in the database are personal (not for the company). Once created, the individual can link themselves to an existing company in the database or add a new one and represent them.

Therefore, will the account in the database be registered under your name?

Please do not hesitate to contact me for further information or any questions.

Best regards,

Karl Kalev Türk
Specialist

Department of Medical Devices

State Agency of Medicines

[email protected]

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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Dear Sir/Madam,

My name is Goda Grybauskaitė. I work in a Lithuanian start-up type company SCI Health. We are interested in placing our UV phototherapy medical device UV Tactus in Estonia. In your web page it states, that we need to submit a notification through the online Estonian Medical Devices and Appliances Database (EMDDB). To place the notification we need to login, however we do not have an account. Is it possible to make one?

Our medical device UV Tactus is a Class II medical device, and it is CE-certified. Our company is also ISO 13485 certified. 

Thank You for your time and I look forward to your response.