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)
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/>