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CERTIFICATE
GMP Certified Lab

01

2024.03

GMP Certified Lab

The company has established a 10,000 square meters production workshop and research laboratory that complies with GMP standards. It has successfully passed the ISO9001 and ISO13485 system certifications.

Manufactory Facilities

28

2024.01

Manufactory Facilities

Founded in 2010, Celnovte is headquartered in Zhengzhou, China for reagent and instrument development and manufacturing. It also has subsidiaries in Shenzhen for instrument R&D, in Suzhou for research-use product development, and in Maryland(USA) for reagent R&D. Our extensive medical instrument manufacturing facilities span 1000m² in Shenzhen, China, and 3000m² in Zhengzhou, China. We also have a GMP-certified lab at the class 10,000 and 100,000 levels, along with supporting research, production, and quality inspection equipment.

ISO9001

03

2024.05

ISO9001

ISO9001

ISO13485

08

2023.03

ISO13485

ISO13485

Certificate of IVD Notification

18

2021.06

Certificate of IVD Notification

Celnovte biotechnology got IVD certificate for 144 products

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CE mark approval

02

2021.06

CE mark approval

Celnovte Biotechnology CE Approval

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