HomeChinaShandong Kanghua Biotechnology Co.,Ltd.

Shandong Kanghua Biotechnology Co.,Ltd.

China · 潍坊 · www.khbio.com
✓ Record-verifiedregistrations found in 2 marketsUnified social credit code 91370700266827355D

This company holds 237 NMPA certificates in China and has registrations in Hong Kong — 1 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
237China registrations
Class I 32Class II 108Class III 97
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 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
3valid listings
IVD D 3
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 Union700 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 3 excluded
China237 certificates (Class III 97 / II 108 / I 32), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil0 confirmed, 6 excluded

Regulatory identity

Unified social credit code
91370700266827355D
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
834
Annual revenue
RMB 100–500M
Website
www.khbio.com
Product categories
体外诊断

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
1996-09-26
Registered capital
CNY 360,000,000
Paid-in capital
CNY 360,000,000
Legal form
Joint-stock limited company (unlisted)
Industry classification
Research and experimental development
Last approval date
2025-11-21
Recognitions
National High-Tech EnterpriseSRDI SMEGazelle enterpriseRecognised enterprise technology centreAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

Business registration data from Tianyancha, as of 2026-09-03. 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253401027乙型肝炎病毒表面抗体检测试剂盒(磁微粒化学发光法)Class III
CN国械注准20253400888乙型肝炎病毒e抗原检测试剂盒(磁微粒化学发光法)Class III
CN国械注准20253400787甲型/乙型流感病毒抗原检测试剂盒(胶体金法)Class III
CN国械注准20253400641乙型肝炎病毒e抗体检测试剂盒(磁微粒化学发光法)Class III

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