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Hangzhou Frenovo Biotech Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000008729

Devices
7
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

Catalogue7

Newest first, rows 1-7 of 7

Company details

EUDAMED SRN
CN-MF-000008729
EU VAT number
91330110MA2J0B8H8X
EUDAMED status
Active
EUDAMED registered name
Hangzhou Frenovo Biotech Co.,Ltd.
Registered address
Room 401,Building 26, Room 401&301,Building 27,No.488-1,Donghu North Road, Donghu Street,LinPing District,Hangzhou City,Zhejiang Province.China., 311100, Hangzhou, China
Phone
+86-571-89170657
PRRC contact
SHERRY HU(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredIVDR 2next expiry 5 Feb 2030

EUDAMED certificates (2)

BSI Group The Netherlands B.V. 2797 2 certificates

  • IVDR 790652 Active

    Quality management system EU IVDR

    Issued
    6 Feb 2025
    Expires
    5 Feb 2030
  • IVDR 790654 Active

    Technical documentation EU IVDR

    Issued
    6 Feb 2025
    Expires
    5 Feb 2030

From the company website

Read 18 Oct 2026

Hangzhou Frenovo Biotech Co., Ltd. is dedicated to R&D and manufacturing of diagnostic test kit with a group of experienced and erudite scientists. Located in Zhejiang and founded in 2020, Frenovo Biotech bear in our mind that it is essential to provide high quality and affordable products for our customers. With products covering fertility, infectious diseases, tumor markers, cardiac markers, inflammation markers and veterinary, we have already obtained CE certificate for Novel Coronavirus Antibody and Antigen tests and Novel Coronavirus Antigen and Flu A+B Combined Tests. More products are under development. Having the whole process operating in strict accordance with the ISO 13485 quality management system, our products are well received by domestic and international users.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Hangzhou Frenovo Biotech Co.,Ltd. have in the registry?

The registry currently lists 7 devices for Hangzhou Frenovo Biotech Co.,Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hangzhou Frenovo Biotech Co.,Ltd.'s devices?

Among its 7 most recently registered devices, Hangzhou Frenovo Biotech Co.,Ltd. has devices listed in EUDAMED (7 devices).

What risk classes do Hangzhou Frenovo Biotech Co.,Ltd.'s devices fall under?

Among its 7 most recently registered devices, the classes recorded for Hangzhou Frenovo Biotech Co.,Ltd.'s devices are IVDR Class B. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Hangzhou Frenovo Biotech Co.,Ltd.?

EUDAMED lists 2 certificates for Hangzhou Frenovo Biotech Co.,Ltd. (quality management system; technical documentation) under IVDR. 2 are recorded with the status issued. The most recent was issued on 6 Feb 2025.

What are the newest devices from Hangzhou Frenovo Biotech Co.,Ltd. in the registry?

The most recently registered devices listed for Hangzhou Frenovo Biotech Co.,Ltd. include hCG Pregnancy Rapid Test Kit (Urine).

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