Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/4463-1 |
| Registreeritud | 24.04.2024 |
| Sünkroonitud | 25.04.2024 |
| Liik | Sissetulev 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 |
Failid
From: Giacomo Pisani <[email protected]>
Sent: Thu, 18 Apr 2024 07:46:01 +0000
To: "[email protected]" <[email protected]>
Subject: 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 |
|
Seosed
| 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 |
| Vastuskiri | 24.04.2024 | 1 | 11.1-2/24/4463-2 | Väljaminev dokument | ta | Materialise NV |