HomeChina必欧瀚生物技术(合肥)有限公司

必欧瀚生物技术(合肥)有限公司

China
✓ Record-verifiedregistrations found in 1 markets

This company holds 90 NMPA certificates in China.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
90China registrations
Class I 26Class II 60Class III 4
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.

China90 certificates (Class III 4 / II 60 / I 26), as of 2026-09-04

Regulatory identity

Exhibition record
CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
278

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
2013-11-13
Registered capital
CNY 48,295,869
Paid-in capital
CNY 48,295,869
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2023-03-30
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMERecognised enterprise technology centreTechnology "Little Giant"State Key Laboratory

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20253401055甲胎蛋白(AFP)检测试剂盒(化学发光法)Class III
CN国械注准20253401048游离前列腺特异性抗原(fPSA)检测试剂盒(化学发光法)Class III
CN国械注准20253400863总前列腺特异性抗原(tPSA)检测试剂盒(化学发光法)Class III
CN国械注准20223401539新型冠状病毒(2019-nCoV)抗原检测试剂盒(胶体金法)Class III

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