HomeChinaHENAN CELNOVTE BIOTECHNOLOGY CO.,LTD

HENAN CELNOVTE BIOTECHNOLOGY CO.,LTD

China · 郑州 · www.celnovte-bio.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000022882Unified social credit code 91410100563705856T

This company holds 572 NMPA certificates in China and has registrations in European Union, United States, Russia — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
572China registrations
Class I 562Class II 5Class III 5
as of 2026-09-04
EUEuropean UnionEUDAMED
35UDI-DI device records
IVD A 35
USUnited StatesFDA openFDA
7listed device types
Class I 7Class II 0Class III 0
plus 7 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
23active registrations
Class 1 4Class 2a 2Class 2b 17
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union35 raw hits, 0 excluded, 35 confirmed
United States7 registration records, 0 510(k), 0 PMA
China572 certificates (Class III 5 / II 5 / I 562), as of 2026-09-04
Manufacturer names merged into this page: CELNOVTE BIOTECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000022882
EU authorised representative
Umedwings Netherlands B.V.
Unified social credit code
91410100563705856T
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
266
Annual revenue
RMB 100–500M
Website
www.celnovte-bio.com
Product categories
医用成像器械

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2010-10-18
Registered capital
CNY 59,010,417
Paid-in capital
CNY 59,010,417
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-12-08
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI SMERecognised enterprise technology centre

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA listed device types

Reagent, Schiff 1Immunohistochemistry Reagents And Kits 1Reagents, Specific, Analyte 1General Purpose Reagent 1Mucicarmine 1Slide Stainer, Automated 1Ph Buffer 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253402158CD20抗体试剂(免疫组织化学法)Class III
CN国械注准20243402106HER2抗体试剂(免疫组织化学法)Class III
CN国械注准20243400374HER2基因扩增检测试剂盒(荧光原位杂交法)Class III
CN国械注准20233400487孕激素受体抗体试剂 (免疫组织化学法)Class III
EU06971804568833AB-PAS stain kitIVD A
EU06971804565597Primary Antibody DiluentIVD A
EU06971804566594Methenamine sliver stain kitIVD A
EU06971804566587Methenamine sliver stain kitIVD A

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →