HomeChinaShanghai Sun Biotech Co., Ltd

Shanghai Sun Biotech Co., Ltd

China · 上海 · www.sunbiote.com.cn
✓ Record-verifiedregistrations found in 2 marketsUnified social credit code 91310112703382172N

This company holds 70 NMPA certificates in China and has registrations in Russia — 1 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
70China registrations
Class I 20Class II 41Class III 9
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
15active registrations
Class 1 3Class 2a 12
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 Union147,820 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 387 excluded
China70 certificates (Class III 9 / II 41 / I 20), as of 2026-09-04
United Kingdom0 confirmed, 71 excluded
Brazil0 confirmed, 188 excluded
Saudi Arabia0 confirmed, 113 excluded
Canada0 confirmed, 30 excluded

Regulatory identity

Unified social credit code
91310112703382172N
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
577
Annual revenue
over RMB 500M
Website
www.sunbiote.com.cn
Product categories
体外诊断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
2001-06-18
Registered capital
CNY 65,000,000
Paid-in capital
CNY 65,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-08-28
Recognitions
National High-Tech EnterpriseInnovative SME

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263401625凝血因子Ⅸ测定试剂盒(凝固法)Class III
CN国械注准20263401473凝血因子Ⅷ测定试剂盒(凝固法)Class III
CN国械注准20263401452蛋白S活性测定试剂盒(凝固法)Class III
CN国械注准20263401282凝血因子异常质控品Class III

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