Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/5545-1 |
| Registreeritud | 29.05.2024 |
| Sünkroonitud | 30.05.2024 |
| 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 | Bemer Int. AG |
| Saabumis/saatmisviis | Bemer Int. AG |
| Vastutaja | Janne Aule (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Jae-Yeon Lepp <[email protected]>
Sent: Tue, 28 May 2024 10:35:07 +0000
To: "[email protected]" <[email protected]>
Subject: EMDDB Account / Foreign Manufacturer
Dear Sir or Madam,
We are a manufacturer of class IIa medical devices according to Regulation (EU) 2017/745 in Liechtenstein and would like to distribute our products in Estonia.
Therefore, we would like to notify the Health Board via the EMDDB.
However, we do not have a distributor who is a holder of an Estonian ID card.
Could you please provide us with a temporary license to use the EMDDB?
Thank you and best regards,
Jae-Yeon Lepp
Jae-Yeon Lepp Regulatory Affairs Manager Bemer Int. AG Austrasse 15 9495 Triesen Principality of Liechtenstein phone: +423 399 3999 email: [email protected] web: www.bemergroup.com |
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Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 29.05.2024 | 1 | 11.1-2/24/5545-2 | Väljaminev dokument | ta | Bemer Int. AG |