Lunit Inc.

• Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
  BelgiumContact the authority →

No certificates registered for this manufacturer.

Devices placed in 32 countries

• Austria8
• Belgium8
• Estonia8
• Finland8
• Netherlands8
• Germany7
• France7
• Croatia7
• Italy7
• Poland7
• XI7
• Cyprus6
• Denmark6
• Spain6
• Norway6
• Sweden6
• Czechia5
• Hungary5
• Latvia5
• Romania5
• Türkiye5
• Bulgaria4
• Iceland4
• Liechtenstein4
• Luxembourg4
• Malta4
• Slovenia4
• Slovakia4
• Ireland3
• Lithuania3
• Greece2
• Portugal2

4 contacts identified

• CS
  PRRC
• PS
  PRRC
• PARK Sunggyun
  1. Before the product is released, ensure that the product is manufactured according to the quality management system. 2. Ensure that post-marketing management systems are established, implemented and maintained in compliance with the MDR. 3. Ensure compliance with MDR 2017/745.
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• CHOI Sulgue
  1. the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, prior to release of the device. 2. the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. 3. the post-market surveillance obligations comply with MDR. 4. appropriate reporting are conducting according to the obligations referred to in MDR. 5. MDR requirements are met.
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• Obelis s.a. — represents — Lunit Inc.
• CHOI Sulgue — Lunit Inc.
• PARK Sunggyun — Lunit Inc.