Now EU IVDR Certified.

Congratulatory Announcement

We are proud to announce: BioTeke Saliva Pregnancy Test Kit is now officially EU IVDR certified for self-testing (CE 3018). After rigorous clinical evaluation, cross-reactivity testing, and a thorough conformity assessment under Regulation (EU) 2017/746, our Saliva Pregnancy Test Kit has received its EU IVDR self-testing certificate — issued by Notified Body CE 3018. This is more than a regulatory milestone. It is confirmation that the pregnancy test market is undergoing a genuine format change — and BioTeke is ready to meet that moment.

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WHY THIS MATTERS FOR B2B PARTNERS 

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✅ Full IVDR compliance — place on the EU market with complete confidence

✅ Documentation package included: Declaration of Conformity, EUDAMED UDI registration, English-language IFU

✅ Immediate availability: OTC self-test formats

✅ Exclusive distribution rights still open in selected EU territories and GCC markets

✅ Clinical performance: Excellent performance for hCG detection in saliva

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WHAT MAKES BIOTEKE SALIVA PREGNANCY TEST DIFFERENT

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The BioTeke Saliva Pregnancy Test Kit detects hCG — the pregnancy hormone — directly from a saliva sample. No urine required. No bathroom needed. Results in 5-10 minutes.

Hygienic. Dignified. Clinically accurate.

We believe every woman deserves a testing experience that respects her privacy and dignity — and we believe distributors, importers, and pharmacy chains deserve a product that stands out on the shelf and generates genuine consumer demand.

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JOIN US AS A STRATEGIC PARTNER 

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If you are an IVD importer, pharmaceutical wholesaler, pharmacy chain, or clinical distributor — we would like to speak with you.

▲ Send us a message or request a sample kit via the link in our bio.

▲ Full regulatory documentation available on request: www.bioteke.cn