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Saatja: 李诗兰 <[email protected]> Saaja: RA MSO Teema: Consulting the procedure of registration of medical devices in Estonia Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Sir or Madam, We are a Chinese manufacturer of medical devices ,which got CE marking. I'd like to know if it's necessary to register our products in State Agency of Medicines before placing them on the Estonian market. If it is necessary,please let me know the procedure of registration of medical devices(class I,IIa,IIb,III) in Estonia. Thank you very much for your time and assistance. Looking forward to your reply. Best Regards, Wendy Li Regulatory Affairs Bain Medical Equipment (Guangzhou) Co., Ltd. Tel: +86 020 66856868-290 Fax: 86-20-32067500 Email: [email protected] <mailto:[email protected]> Website:http://www.bainmedical.com/ 李诗兰<[email protected]> 在 2025年4月23日 周三 11:42 写道： Dear Sir or Madam, We are a Chinese manufacturer of medical devices ,which got CE marking. I'd like to know if it's necessary to register our products in State Agency of Medicines before placing them on the Estonian market. If it is necessary,please let me know the procedure of registration of medical devices(class I,IIa,IIb,III) in Estonia. Thank you very much for your time and assistance. Looking forward to your reply. Best Regards, Wendy Li Regulatory Affairs Bain Medical Equipment (Guangzhou) Co., Ltd. Tel: +86 020 66856868-290 Fax: 86-20-32067500 Email: [email protected] <mailto:[email protected]> Website:http://www.bainmedical.com/