RFBio Co., Ltd

• Urząd Rejestracji Produktów Leczniczych
  PolandContact the authority →

No certificates registered for this manufacturer.

Devices placed in 3 countries

• Türkiye6
• Italy1
• XI1

2 contacts identified

• LD
  LEE Dong-Won

  PRRC
  View profile →
• JIN Sung-Hye
  ensuring that: - the conformity of the devices is appropriately checked, in accordance with QMS, - TD and the EU DoC are drawn up and kept up-to-date; - the PMS obligations are complied with Art.10, - the reporting obligations from Art. 87 to 91 are fulfilled; (e) in the case of investigational devices, obligations acc. To Annex XV fulfilled.
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• MDR Regulator Sp. z o. o. — represents — RFBio Co., Ltd
• LEE Dong-Won — RFBio Co., Ltd