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Shanghai Chemtron Biotech Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000018072

Devices
76
Registrations
EUDAMED

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.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED SRN
CN-MF-000018072
EU VAT number
913101156074267293
EUDAMED status
Active
EUDAMED registered name
Shanghai Chemtron Biotech Co., Ltd.
Registered address
No. 518, Qingdai Rd., International Medical Park, Pudong, 201318, Shanghai, PEOPLE'S REPUBLIC OF CHINA, 201318, Shanghai, China
Phone
86-17521018699
PRRC contact
Yuyu Liu(public in EUDAMED)

EUDAMED certificates3

3 certificates3 valid, 0 expiredIVDR 3next expiry 8 Oct 2031

EUDAMED certificates (3)

TÜV SÜD Product Service GmbH 0123 3 certificates

  • V76 076482 0013 Active

    Technical documentation EU IVDR

    Issued
    13 Oct 2026
    Expires
    12 Oct 2031
  • V76 076482 0015 Active

    Technical documentation EU IVDR

    Issued
    12 Oct 2026
    Expires
    11 Oct 2031
  • V76 076482 0014 Active

    Technical documentation EU IVDR

    Issued
    9 Oct 2026
    Expires
    8 Oct 2031

From the company website

Read 18 Sep 2026

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.

From the manufacturer's own website. Source