dokumendiregister.ee
Sissetulev kiriAvalik

Küsimused

Ravimiamet · 4. juuli 2025
Viit
MSO-2/3368-1
Registreeritud
4. juuli 2025
Dokumendi liik
Sissetulev kiri
Adressaat
SJJ Solutions B.V.
Saabumis/saatmisviis
e-post
Funktsioon
MSO Meditsiiniseadmed
Sari
MSO-2 Eesti turule lastavate/kasutusele võetavate/levitatavate seadmete teavitused ning EC sertifikaadid
Toimik
MSO-2/2025
Vastutaja
Karl Kalev Türk (RA, Meditsiiniseadmete osakond)

Failid

Sisu (failidest)

Saatja: Wessel Hornman <[email protected]> Saaja: RA MSO Teema: Registration Zero Residual concept Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Sir/Madam, My name is Wessel Hornman, and I am working at SJJ Solutions B.V., a medical device company based in The Hague, The Netherlands. We have developed the 'Zero Residual' concept for tailored for intravitreal injections. The concept includes the following: * 0.2 mL silicone oil-free syringe * 30G and 33G injection needles * Bubble adapter: pharmacy ancillary for filling of the syringes * Filter needle 18G and 23G * Caps: luer lock cap and plunger shield for storage of the prefilled syringes We are seeing increasing interest from ophthalmologists in Estonia and would like to start selling our products. We have CE and 510(k) registration. What are the next steps for registration in Estonia? Looking forward to your reply. Best regards, Wessel Hornman Business Developer Prinses Alexialaan 70B – 2nd Floor | 2496XA The Hague – The Netherlands T: +31 (0)6 24621721 | www.SJJSolutions.com <http://www.sjjsolutions.com/>
Allikas: Ravimiamet dokumendiregister →