HomeChina杭州博拓生物科技股份有限公司

杭州博拓生物科技股份有限公司

China · 杭州 · www.biotests.com.cn
✓ Record-verifiedregistrations found in 1 marketsUnified social credit code 9133010079969193XF

This company holds 67 NMPA certificates in China.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
67China registrations
Class I 4Class II 15Class III 34
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
pendingnot queried
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.

China67 certificates (Class III 34 / II 15 / I 4), as of 2026-09-04

Regulatory identity

Unified social credit code
9133010079969193XF
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
519
Annual revenue
over RMB 500M
Website
www.biotests.com.cn
Product categories
临床检验器械及试剂

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
2008-11-28
Registered capital
CNY 149,333,334
Paid-in capital
CNY 149,333,334
Legal form
Joint-stock limited company (listed)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-06-25
Recognitions
National High-Tech EnterpriseFledgling enterpriseRecognised enterprise technology centreInnovative SMEAbove-designated-size industrial enterprise
Listing
Listed on the STAR Market

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20253402140梅毒螺旋体抗体检测试剂(胶体金法)Class III
CN国械注准20253402129梅毒螺旋体抗体、人类免疫缺陷病毒抗体联合检测试剂(胶体金法)Class III
CN国械注准20253401969人类免疫缺陷病毒(HIV 1/2)抗体检测试剂(胶体金法)Class III
CN国械注准20243402634甲胎蛋白(AFP)检测试剂(荧光免疫层析法)Class III

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