Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/6205-1 |
| Registreeritud | 07.06.2024 |
| Sünkroonitud | 10.06.2024 |
| 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 | 11.1-2/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | New Ancorvis s.r.l |
| Saabumis/saatmisviis | New Ancorvis s.r.l |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "[email protected]" <[email protected]>
Sent: Wed, 05 Jun 2024 06:27:12 +0000
To: [email protected]; "Passarini; Samuela (New Ancorvis)" <[email protected]>
Subject: Estonia: Procedure to sell Medical Devices
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu
saatja korral palume linke ja faile mitte avada. |
To whom it may concern,
I'm kindly asking to know the right procedure in order to sell
Medical Devices in your National Market.
Before Eudamed will be completely operative, the rules to sell
Medical Devices in all European contries are different and every
Nation has his own rules (For examples: in some nations it's
correct just to make a right registration of MDs in Eudamed
platform; in others to follow the correct procedure it's necessary
send a Declaration with all the categories of products the Factory
is going to sell in the specific National Market; some States want
an individual registration of each Medical Device or sometimes the
rules are different from a Class to risk to an other).
We specify that:
- New Ancorvis s.r.l is an Italian Factory that produces and
certifies class I - IIa - IIb Medical Devices
- New Ancorvis has a correct registration as Medical Device Manufacture in Eudamed
- New Ancorvis has a correct registration of his products in
Italian Medical device database
- New Ancorvis Factory has MDR certification with the notify body ICIM 0425
Looking forward your response, thank you for your kind collaboration.
Best Regards
Marianna Govoni
Via dell'Industria,15
40012 Bargellino- Calderara di Reno (BO) -Italy
Fax: +39 051 6463076
E-mail: [email protected]
Website: www.newancorvis.eu
P.I./ C.F.: 01878171204SDI: 5RUO82D
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