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- 02. Acquired ISO 13485 Certification for lancets
- 02. Obtained FDA Certification for vaccine syringes
- 11. Acquired ISO 13485 Certification for safety lancets
- Acquired ISO 13485 Certification for safety lancets
- Registered pen needles and safety pen needles in Russia
- 10. Expanded production line for lancets
- 12. Development of safety lancets in progress
- 10. Completed registration of general pen needles and safety pen needles with Health Canada
- 09. Obtained Medical Device Single Audit Program (MDSAP) Certification
- 08. Completed design registration for three items including “medical needle support” for safety pen needles
- 07. Changed notified body (SGS → TÜV Rheinland)
- 02. Completed registration of general pen needles with the Therapeutic Goods Administration (TGA) in Australia
- 04. Acquired CEMDD Certification for safety pen needles and obtained medical device manufacturing certification for safety pen needles
- 01. Selected as a Next-Generation World-Class Product for safety pen needles
- 12. Obtained ANVISA Certification
- 12. Awarded 5 Million Dollar Export Tower
- 11. Selected as a participant in the P300 Project
- 08. Obtained CFDA Certification
- 07. Obtained ANVISA Certification
- 11. Change in Major Shareholder
- 08. Expanded manufacturing line for pen needles
- 07. Obtained Good Manufacturing Practice (GMP) Certification for medical devices
- 06. Acquired CE and ISO 13485 Certifications
- 08. Received FDA 510K Approval
- 05. Obtained manufacturing approval for insulin pen needles
- 12. Acquired Medical Device Manufacturing License from the Ministry of Food and Drug Safety of the Republic of Korea (MFDS)
- 01. Established MedExel Co., Ltd.
