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Hangzhou New Horizon Health Technology Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000027517

Devices
11
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates

What Hangzhou New Horizon Health Technology Co., Ltd. makes

The company manufactures diagnostic devices for HPV detection, including a high-risk HPV DNA test using PCR-fluorescence probing technology, as well as nucleic acid extraction and purification reagents and kits for laboratory use. It also produces sample collection and preservation tubes for cervical, vaginal, and urine specimens, alongside software for combined genetic mutation and methylation analysis in colorectal cancer screening. Additional offerings include a device for fecal immunochemical testing (FIT) and a reusable UU tube for medical procedures.

The portfolio includes in vitro diagnostic (IVD) devices classified under Class A and IVD General, with some products registered in the EU’s eudamed database. The company is based in China and adheres to relevant regulatory frameworks for diagnostic medical devices in its market and export jurisdictions.

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-000027517
EUDAMED status
Active
EUDAMED registered name
Hangzhou New Horizon Health Technology Co., Ltd.
Registered address
Room 110, 1st Floor, Building 2, No.475 Changhe Road, Changhe Sub-district, Binjiang District, 310052, Hangzhou City, Zhejiang, China
Phone
+86 400 826 2300
PRRC contact
Liya Feng(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredIVDR 2next expiry 1 Apr 2030

EUDAMED certificates (2)

BSI Group The Netherlands B.V. 2797 2 certificates

  • IVDR 818165 Active Supplemented

    Technical documentation EU IVDR

    Issued
    17 Aug 2026
    Expires
    8 Sep 2030
    Reason
    Change approved
  • IVDR 796427 Active Supplemented

    Technical documentation EU IVDR

    Issued
    17 Aug 2026
    Expires
    1 Apr 2030
    Reason
    Change approved

From the company website

Read 18 Oct 2026

THE FIRST HIGH-TECH COMPANY IN CHINA, WHICH FOCUSES ON EARLY CANCER SCREENING, HAS PIONEERED THE CONCEPT OF SERVICES FOR “EARLY HOME SCREENING FOR HIGH-PREVALENCE CANCER”. ITS OWN “NON-INTRUSIVE, MULTI-TARGET FIT-DNA JOINT TEST” PRODUCT - THE FIRST EVER IN CHINA AND THE ONLY EARLY SCREENING PRODUCT FOR ENTERIC CANCER AT THIS STAGE. THE PRODUCT LINE COVERS AREAS SUCH AS ENTERIC, CERVICAL, STOMACH AND LUNG CANCER. WITH REGARD TO THE HIGH INCIDENCE OF CANCER AMONG CHINESE PEOPLE, NOBUMI HEALTH IS COMMITTED TO PROVIDING THE MOST APPROPRIATE EARLY SCREENING SOLUTIONS, SO THAT USERS CAN HAVE ACCESS TO EARLY CANCER SCREENING SERVICES THAT ARE ACCURATE, EFFICIENT AND ACCESSIBLE。

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does Hangzhou New Horizon Health Technology Co., Ltd. have in the registry?

The registry currently lists 11 devices for Hangzhou New Horizon Health Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hangzhou New Horizon Health Technology Co., Ltd.'s devices?

Among its 11 most recently registered devices, Hangzhou New Horizon Health Technology Co., Ltd. has devices listed in EUDAMED (11 devices).

What risk classes do Hangzhou New Horizon Health Technology Co., Ltd.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Hangzhou New Horizon Health Technology Co., Ltd.'s devices are IVDR Class A, IVDR Class C and IVD general. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Hangzhou New Horizon Health Technology Co., Ltd.?

EUDAMED lists 2 certificates for Hangzhou New Horizon Health Technology Co., Ltd. (technical documentation) under IVDR. The most recent was issued on 17 Aug 2026.

What are the newest devices from Hangzhou New Horizon Health Technology Co., Ltd. in the registry?

The most recently registered devices listed for Hangzhou New Horizon Health Technology Co., Ltd. include PuPu Tube, UU Tube, High-risk Human Papillomavirus (HPV) DNA Test (PCR-Fluorescence Probing) and ColoClear.

Generated automatically from registry data and not verified by a human reviewer.