Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/5975-1 |
| Registreeritud | 06.06.2024 |
| Sünkroonitud | 07.06.2024 |
| 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 | 11.1-2/2023 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Arazy group |
| Saabumis/saatmisviis | Arazy group |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Miki Melech <[email protected]>
Sent: Fri, 07 Oct 2022 07:56:43 +0000
To: [email protected]
Subject: Notification of Class IIb Software application
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sir / Madam
Our client approached us to assist with the medical device notification in Estonia
They have a Class IIb Software application, CE approved by TUV Rheinland. due to the fact it is a SW application, they do not have a distributor in Estonia.
The manufacturer is not located in the EU but has an EU AR (in the Netherlands) and importers located in 2 EU countries (not in Estonia)
the device is for home use only and they do not have a domestic distributor or importer in Estonia.
all Economic operators already registered in EUDAMED and have SRN number
Is the device subject to any device notification in Estonia?
will appreciate your reply
Kind regards
Miki
Miki Melech
Head of EU Division / Senior Regulatory Expert
Email: [email protected] | Skype: michalmel | Mobile: +972.50.884.1024
Web: http://arazygroup.com | Office: Manof, Israel | Phone: +972.4.994.7880
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 06.06.2024 | 1 | 11.1-2/24/5975-6 🔒 | Väljaminev dokument | ta | Arazy group |
| Kiri | 06.06.2024 | 1 | 11.1-2/24/5975-14 🔒 | Väljaminev dokument | ta | Arazy group |
| Kiri | 06.06.2024 | 1 | 11.1-2/24/5975-8 🔒 | Väljaminev dokument | ta | Arazy group |
| Vastuskiri | 06.06.2024 | 1 | 11.1-2/24/5975-5 🔒 | Sissetulev dokument | ta | Arazy group |
| Vastuskiri | 06.06.2024 | 1 | 11.1-2/24/5975-4 | Väljaminev dokument | ta | Arazy group |
| Kiri | 06.06.2024 | 1 | 11.1-2/24/5975-3 | Sissetulev dokument | ta | Arazy group |
| Kiri | 06.06.2024 | 1 | 11.1-2/24/5975-9 🔒 | Sissetulev dokument | ta | Arazy group |
| Vastuskiri | 06.06.2024 | 1 | 11.1-2/24/5975-12 🔒 | Väljaminev dokument | ta | Arazy group |
| Vastuskiri | 06.06.2024 | 1 | 11.1-2/24/5975-10 🔒 | Väljaminev dokument | ta | Arazy group |
| Vastuskiri | 06.06.2024 | 1 | 11.1-2/24/5975-11 🔒 | Sissetulev dokument | ta | Arazy group |
| Vastuskiri | 06.06.2024 | 1 | 11.1-2/24/5975-13 🔒 | Sissetulev dokument | ta | Arazy group |
| Kiri | 06.06.2024 | 1 | 11.1-2/24/5975-7 🔒 | Sissetulev dokument | ta | Arazy group |
| Kiri | 06.06.2024 | 1 | 11.1-2/24/5975-2 | Väljaminev dokument | ta | Arazy group |