| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/1246-1 |
| Registreeritud | 31.01.2024 |
| Sünkroonitud | 27.03.2024 |
| 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 | Swedish Orphan Biovitrum AB |
| Saabumis/saatmisviis | Swedish Orphan Biovitrum AB |
| Vastutaja | Merili Saar (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
From: Ravimiamet <[email protected]>
Sent: Thu, 05 Oct 2023 09:55:16 +0000
To: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Subject: Ed: ‘Medical devices and appliances database’ registration
Tere
Edastan pöördumise.
Lugupidamisega
Keiu Põderson
Ravimiamet
Järelevalveosakond
spetsialist
Tel 737 4140
Nooruse 1
50411 Tartu
Selles e-kirjas sisalduv teave (kaasa arvatud manused) on mõeldud ametialaseks kasutamiseks ning seda võivad kasutada vaid e-kirja adressaadid. E-kirjas sisalduvat teavet ei tohi ilma saatja selgelt väljendatud loata edasi saata ega mis tahes viisil kolmandatele isikutele avaldada. Juhul, kui Te olete saanud käesoleva e-kirja eksituse tõttu, teavitage sellest koheselt saatjat ning kustutage e-kiri.
This e-mail and any attachments transmitted may contain confidential and privileged information. If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal.
Saatja: Alexandra Lindeberg <[email protected]>
Saatmisaeg: neljapäev, 5. oktoober 2023 12:35
Adressaat: Ravimiamet <[email protected]>
Koopia: Jan Rydberg <[email protected]>
Teema: ‘Medical devices and appliances database’ registration
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Does Sobi AB located in Stockholm Sweden has to register with ‘Medical devices and appliances database’ as Distributor according to EU MDR (745/2017) when distributing CE-marked medical device on the Estonian market?
Thank you very much for your support and guidance in advance.
Best regards,
Alexandra Lindeberg, M.Sc. Pharm
Medical Affairs Manager Nordics & Baltics
_____________________________
Switch board +46 8 697 2000, Mobile +46 720832510
[email protected]
Swedish Orphan Biovitrum AB
SE-112 76 Stockholm, Sweden
Visitors: Tomtebodavägen 23A, Solna
www.sobi.com
www.sobi.se
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| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 31.01.2024 | 56 | 11.1-2/24/1246-2 | Väljaminev dokument | ta | Swedish Orphan Biovitrum AB |