Shanghai Chemtron Biotech Co., Ltd.
China Last updated 21 Oct 2026
- Devices
- 76
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
One Step HCG Pregnancy Test Ref 6001C31SN10
One Step HCG Pregnancy Test Ref 6001S31SN2
One Step LH Ovulation Test Ref 6002C31SN5
FOB Fecal Occult Blood Rapid Test Ref 9001T61SN10
One Step LH Ovulation Test Ref 6002C31SN20
One Step LH Ovulation Test Ref 6002S31SN2
One Step HCG Pregnancy Test Ref 6001C31SN25
One Step HCG Pregnancy Test Ref 6001D31SN5
FOB Fecal Occult Blood Rapid Test Ref 9001C61SN10
FOB Fecal Occult Blood Rapid Test Ref 9001T61SN20
Influenza A+B Antigen Combo Rapid Test Ref 8062C01
One Step LH Ovulation Test Ref 6002D31SN25
One Step HCG Pregnancy Test Ref 6001C31SN20
One Step HCG Pregnancy Test Ref 6001C31SN3
One Step HCG Pregnancy Test Ref 6001S31SN25
One Step HCG Pregnancy Test Ref 6001D31SN2
One Step LH Ovulation Test Ref 6002C31SN2
One Step HCG Pregnancy Test Ref 6001S31SN5
FOB Fecal Occult Blood Rapid Test Ref 9001C61SN3
One Step HCG Pregnancy Test Ref 6001D31SN1
One Step LH Ovulation Test Ref 6002D31SN1
FOB Fecal Occult Blood Rapid Test Ref 9001C61SN5
FOB Fecal Occult Blood Rapid Test Ref 9001T61SN3
One Step LH Ovulation Test Ref 6002S31SN3
One Step HCG Pregnancy Test Ref 6001C31SN2
One Step HCG Pregnancy Test Ref 6001D31SN3
One Step HCG Pregnancy Test Ref 6001D31SN20
One Step LH Ovulation Test Ref 6002S31SN25
FOB Fecal Occult Blood Rapid Test Ref 9001
One Step LH Ovulation Test Ref 6002D31SN20
HP Ag H.pylori Antigen Rapid Test Ref 8022
FOB Fecal Occult Blood Rapid Test Ref 9001C61SN1
One Step LH Ovulation Test Ref 6002C31SN10
One Step HCG Pregnancy Test Ref 6001D31SN25
One Step LH Ovulation Test Ref 6002C31SN3
FOB Fecal Occult Blood Rapid Test Ref 9001T61SN2
FOB Fecal Occult Blood Rapid Test Ref 9001T61SN5
FOB Fecal Occult Blood Rapid Test Ref 9001T61SN25
FOB Fecal Occult Blood Rapid Test Ref 9001C61SN25
One Step LH Ovulation Test Ref 6002D31SN2
One Step LH Ovulation Test Ref 6002D31SN10
One Step LH Ovulation Test Ref 6002D31SN3
One Step LH Ovulation Test Ref 6002S31SN10
One Step HCG Pregnancy Test Ref 6001S31SN20
FOB Fecal Occult Blood Rapid Test Ref 9001C61SN2
One Step LH Ovulation Test Ref 6002S31SN5
One Step HCG Pregnancy Test Ref 6001S31SN3
FOB Fecal Occult Blood Rapid Test Ref 9001C61SN20
One Step LH Ovulation Test Ref 6002D31SN5
Showing 1-50 of 76
EUDAMED certificates
TÜV SÜD Product Service GmbH 0123 3 certificates
- V76 076482 0013 Issued
Technical documentation EU IVDR
- Issued
- 13 Oct 2026
- Expires
- 12 Oct 2031
- V76 076482 0015 Issued
Technical documentation EU IVDR
- Issued
- 12 Oct 2026
- Expires
- 11 Oct 2031
- V76 076482 0014 Issued
Technical documentation EU IVDR
- Issued
- 9 Oct 2026
- Expires
- 8 Oct 2031
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About
Shanghai Chemtron Biotech Co.,Ltd. has about 10 years in aesthetic medical technologies production and marketing. Our company aspire to be the leader and innovator in the beauty area. Therefore, under the guidance of this goal, both the product line or quality of our products are at the forefront.
What Shanghai Chemtron Biotech Co., Ltd. makes
Shanghai Chemtron Biotech Co., Ltd. manufactures rapid diagnostic tests for at-home and point-of-care use, including pregnancy, ovulation, menopause, and fecal occult blood assessments. Their product line also covers infectious disease testing, such as COVID-19, influenza, RSV, adenovirus, chlamydia, and *Helicobacter pylori* antigen detection, as well as prostate-specific antigen screening.
These devices fall under EU In Vitro Diagnostic Regulation (IVDR) classifications, including Annex II List B, general IVD categories, and self-testing devices. They are registered in the EU’s eudamed database, and the company is based in China.
Frequently asked questions
How many devices does Shanghai Chemtron Biotech Co., Ltd. have in the registry?
The registry currently lists 76 devices for Shanghai Chemtron Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shanghai Chemtron Biotech Co., Ltd.'s devices?
Among its 50 most recently registered devices, Shanghai Chemtron Biotech Co., Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do Shanghai Chemtron Biotech Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Shanghai Chemtron Biotech Co., Ltd.'s devices are IVDR Class B and IVDR Class C. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Shanghai Chemtron Biotech Co., Ltd.?
EUDAMED lists 3 certificates for Shanghai Chemtron Biotech Co., Ltd. (technical documentation) under IVDR. 3 are recorded with the status issued. The most recent was issued on 2026-10-13.
What are the newest devices from Shanghai Chemtron Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Shanghai Chemtron Biotech Co., Ltd. include One Step HCG Pregnancy Test, One Step LH Ovulation Test, FOB Fecal Occult Blood Rapid Test and Multiple Drug of Abuse Test AMP-BAR-BZO-COC-MET-MDMA-MOR-MTD-TCA-THC.
Information
- Address
- No. 518, Qingdai Rd., International Medical Park, Pudong, 201318, Shanghai, PEOPLE'S REPUBLIC OF CHINA , Shanghai, China
- Website
- www.chemtronbio.com
- [email protected]
- Phone
- 86-17521018699
- PRRC contact
- Yuyu Liu
- EUDAMED SRN
- CN-MF-000018072