Hangzhou New Horizon Health Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000027517
- Devices
- 11
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- Authorised rep.
- Riomavix Sociedad LimitadaES
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.
Catalogue
Search and filter all 11 devicesCompany 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
- Website
- www.newhorizonbio.com
- [email protected]
- Phone
- +86 400 826 2300
- PRRC contact
- Liya Feng
EUDAMED certificates
2 certificates2 valid, 0 expiredIVDR 2next expiry 1 Apr 2030
BSI Group The Netherlands B.V. 2797 2 certificates
- IVDR 818165 Active
Technical documentation EU IVDR
- Issued
- 17 Aug 2026
- Expires
- 8 Sep 2030
- Reason
- Change approved
- IVDR 796427 Active
Technical documentation EU IVDR
- Issued
- 17 Aug 2026
- Expires
- 1 Apr 2030
- Reason
- Change approved
From the company website
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。
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.