Dokumendiregister | Terviseamet |
Viit | 11.1-2/24/4463-2 |
Registreeritud | 24.04.2024 |
Sünkroonitud | 25.04.2024 |
Liik | Väljaminev dokument |
Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
Sari | 11.1-2 Kirjavahetus Eesti turule lastavatest/kasutusele võetavatest/levitatavatest seadmetest MSA kaudu teavitamiseks |
Toimik | 11.1-2/2024 |
Juurdepääsupiirang | Avalik |
Juurdepääsupiirang | |
Adressaat | Materialise NV |
Saabumis/saatmisviis | Materialise NV |
Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
Originaal | Ava uues aknas |
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Tue, 23 Apr 2024 08:19:49 +0000
To: Giacomo Pisani <[email protected]>
Subject: Vs: Registration and submission in EMDBB
Dear Giacomo,
Thank you for your letter.
Indeed, we can create an account in the database manually in cases where there is no possibility to use secure authentication services.
The account itself is personal (not for the company). The person then adds the company to the database and links themselves to it.
Therefore, should the EMDDB account be registered under your name? If not, please provide the name and email. We will then send the login credentials for the EMDDB.
Please do not hesitate to contact me for further information or any questions.
Best regards,
Karl Kalev Türk
Chief Specialist
Department of Medical Devices
Phone +372 5648 5663
[email protected] | [email protected]
Republic of Estonia Terviseamet | Health Board +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn Estonia |
This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.
Saatja: Giacomo Pisani <[email protected]>
Saatmisaeg: neljapäev, 18. aprill 2024 10:46
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Teema: Registration and submission in EMDBB
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
To whom it may concern,
I am Giacomo Pisani, Regulatory Affairs Specialist for Materialise NV, Belgian-based Manufacturer.
I am reaching you out since we are facing some issues to register in EMDBB to notify our Class IIa and above devices.
In particular, since we are based in Belgium and not in Estonia, we do not have any ID to complete the registration. In the guidance is written that in special cases you can proceed creating manually the account.
Please could you confirm how we should move forward?
Thank you in advance for your cooperation.
Kind regards,
Giacomo Pisani
Regulatory Affairs Specialist Materialise NV Technologielaan 15 3001 Leuven Belgium |
Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
---|---|---|---|---|---|---|
Vastuskiri | 03.05.2024 | 3 | 11.1-2/24/4463-6 🔒 | Sissetulev dokument | ta | Materialise NV |
Vastuskiri | 30.04.2024 | 1 | 11.1-2/24/4463-5 🔒 | Väljaminev dokument | ta | Materialise NV |
Vastuskiri | 30.04.2024 | 1 | 11.1-2/24/4463-4 🔒 | Sissetulev dokument | ta | Materialise NV |
Vastuskiri | 24.04.2024 | 1 | 11.1-2/24/4463-3 | Sissetulev dokument | ta | Materialise NV |
Kiri | 24.04.2024 | 1 | 11.1-2/24/4463-1 | Sissetulev dokument | ta | Materialise NV |