| Dokumendiregister | Terviseamet |
| Viit | 11.1-12/24/1244-1 |
| Registreeritud | 31.01.2024 |
| Sünkroonitud | 27.03.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-12 Turujärelevalvega seotud muu kirjavahetus („tahetakse infot“) - Nõustamine |
| Toimik | 11.1-12/2023 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Becton, Dickinson and Company |
| Saabumis/saatmisviis | Becton, Dickinson and Company |
| Vastutaja | Merili Saar (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: Barbara Björkbom <[email protected]>
Sent: Fri, 06 Oct 2023 06:00:24 +0000
To: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Subject: eIFU for IVDs
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sir/Madam,
I am contact you in regards to the acceptance of eIFU in Estonia
Is acceptable only eIFU for IVDs for professional use devices (e.g. equipment and assay to be run on it) that are going to be use by lab technicians.
I thank you in advance for your support!
Best regards,
Barbara Björkbom
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| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 31.01.2024 | 56 | 11.1-12/24/1244-2 | Väljaminev dokument | ta | Becton, Dickinson and Company |