Quality & compliance
BIOLOT supports professional partners with production licensing, quality-system documentation, product-specific technical files and market-aware documentation service.
Provide the exact product code and destination market so we can match the available IFU, SDS and market-specific documents.
Company credentials
View BIOLOT's company qualifications and innovation milestones. Contact our team for current documents and the scope applicable to your project.
Term shown: 30 Aug 2022–29 Aug 2027
Our production licence covers Class II category 6840—clinical laboratory analytical instruments and in-vitro diagnostic reagents.
Issued by Hubei Medical Products Administration · licence issued 29 Aug 2025Certification term: 15 May 2024–14 May 2027
CMD's July 2024 certification bulletin lists Beijing Biolot (Wuhan) Science and Trade Co., Ltd. under GB/T 42061-2022 idt ISO 13485:2016 for the design, development, production and service of the specified reagent and analyzer-fluid scope.
View CMD certification bulletin Certification scope is defined by the applicable certificate and certification-body registerFour patent grants · 2023–2024
BIOLOT received two utility-model patent grants in 2023 and one utility-model plus one invention-patent grant in 2024.
Patent legal status is available through the official patent registerCertificate term shown: 14 Jun 2024–13 Jun 2034
The BIOLOT trademark is registered in Nice Classes 5 and 10 to Beijing Biolot Technology Development Co., Ltd.
Trademark registration term and scope are defined by the registration certificateCertificate scope and applicability may vary by product and destination market. Contact us for current documents for qualification, registration or distribution needs.
Partner support
Our team connects company qualifications, product information and destination-market documentation with your specific sourcing or registration needs.
We provide the applicable quality-system certificate and scope for qualification, registration and distribution needs.
Request supporting documentsOur Wuhan base supports product development, manufacturing and operational service, with the current R&D and production building completed in 2013.
Request supporting documentsOur team matches available certificates and registration documents to the relevant product and destination market.
Request supporting documentsWe support product evaluation with SKU- and analyzer-specific protocols, results and acceptance criteria where applicable.
Request supporting documentsStorage conditions and shelf life are provided through the applicable IFU or product technical file.
Request supporting documentsProduct classification and market requirements vary by intended use and country; we help partners identify the documentation relevant to each project.
Request supporting documentsThird-party manufacturer and instrument names are used only to identify compatibility. BIOLOT is not affiliated with, authorized by, sponsored by, or endorsed by those manufacturers.
Browse compatibility pagesTechnical documents
Download public references immediately or contact us for the IFU, SDS, certificate or technical file applicable to your product and market.
Warehousing & fulfilment
Defined storage areas and outbound preparation support day-to-day product handling at the Wuhan operation.
