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About Us / Qualifications and Honors

Expand from R&D team to experienced operation team
in Finance/ Sales/Marketing /HR

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Cell quality report from NIFDC

2 cell quality reports from NIFDC (the most authoritative cell quality report, passed the preliminary inspection in just 2 months (No: SH202400986 & SH202401009)

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DMF and CE registrations

中科睿极微载体、培养基及重组温和消化酶共获得14项美国DMF备案及2项CE备案(截至2024年6月),产品生产与品控与国际标准接轨,满足客户各阶段需求,助力药物合规申报。

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Registered as a pharmaceutical excipient

Registered as a pharmaceutical excipient
China No.: F20220000380, US FDA MF #: 29520

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National medical products administration medical device qualification

NMPA Class I device No. : Yue Chan 20230036, 20240151 & 20240142; Completed the production registration of Class I medical devices for in vitro diagnostic reagents, ensuring that the products comply with regulatory requirements.

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Quality system certification

ISO 13485:2016 medical devices quality management system
ISO 9001:2015 quality management system
ISO 14001:2015 environmental management system
ISO 45001:2018 occupational health and safety management system
By adhering to standardized and regulated management processes, we enhance the quality level of our products and services to meet customer needs and expectations.

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Patents and software copyrights

Applied 118 PCs and 83 granted patents (as of May 2025)

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Group standards

Organize & participate in 8 group standards

Honors

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Top 50 biotechnology innovation enterprises in greater bay area (2023)

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KPMG China tech innovator 2023 (the second prize in China, the first prize in the biotechnology and pharmaceutical)

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High-tech enterprise certification

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The first prize winner of the 5th national creative innovation and entrepreneurship competition “Zhaoshang Cup"

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Shenzhen fastest-growth enterprise top 100 (ranked as 17th in 2022)

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Top 10 annual outstanding local equipment suppliers in the field of innovative biopharmaceuticals

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The first prize of 2022 China eye valley vision optometry innovation and entrepreneurship global challenge

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Selected for the "Rising stars in cell culture solutions" list in the CGT field

We cordially invites you to
explore the infinite potential of
stem cells and exosomes

Scan the QR Code to learn more about us
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