Dokumendiregister | Terviseamet |
Viit | 11.1-2/24/11608-1 |
Registreeritud | 13.11.2024 |
Sünkroonitud | 14.11.2024 |
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 | Healy World GmbH |
Saabumis/saatmisviis | Healy World GmbH |
Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
Originaal | Ava uues aknas |
From: "Stefanie Friesen (DE)" <[email protected]>
Sent: Tue, 09 May 2023 10:07:10 +0000
To: "[email protected]" <[email protected]>
Subject: Question for notification of a medical device with bluetooth
Dear Sir or Madame,
we have a medical device that we may want to sell in Estonia. For this we need to notify it according to your website.
This medical device works with Bluetooth. My question now is whether we also need to register Bluetooth? And if so, do you also know where or with whom?
Best regards
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Stefanie Friesen Healy World GmbH Office Berlin |
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District court Mainz · Hreg. No.: HRB 51379· VAT No.: DE 323365608 · CEO: Christian Dorner |
![]() ![]() | Stefanie Friesen Regulatory Affairs Manager +4915164334181 | [email protected] Healy World GmbH Mariendorfer Damm 1-3 12099 Berlin ![]() ![]() ![]() ![]() ![]() | |
District court Mainz · Hreg. No.: HRB 51379· VAT No.: DE 323365608 · CEO: Christian Dorner |
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Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
---|---|---|---|---|---|---|
Kiri | 13.11.2024 | 1 | 11.1-2/24/11608-4 | Väljaminev dokument | ta | Healy World GmbH |
Kiri | 13.11.2024 | 1 | 11.1-2/24/11608-2 | Väljaminev dokument | ta | Healy World GmbH |
Kiri | 13.11.2024 | 1 | 11.1-2/24/11608-5 | Sissetulev dokument | ta | Healy World GmbH |
Kiri | 13.11.2024 | 1 | 11.1-2/24/11608-8 | Väljaminev dokument | ta | Healy World GmbH |
Kiri | 13.11.2024 | 1 | 11.1-2/24/11608-7 | Sissetulev dokument | ta | Healy World GmbH |
Kiri | 13.11.2024 | 1 | 11.1-2/24/11608-3 | Sissetulev dokument | ta | Healy World GmbH |
Kiri | 13.11.2024 | 1 | 11.1-2/24/11608-6 | Sissetulev dokument | ta | Healy World GmbH |