HomeChinaBeijing Hotgen Biotech Co., Ltd

Beijing Hotgen Biotech Co., Ltd

China · Beijing · www.hotgenbiotech.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000015566

This company has registrations in European Union, United States, United Kingdom, Brazil, Russia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
71UDI-DI device records
IVD A 3IVD B 40IVD C 28
USUnited StatesFDA openFDA
13listed device types
Class I 9Class II 3Class III 0unclassified 1
plus 13 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
5registered device records
IVD general 4IVD Devices for Self-Testing 1
BRBrazilANVISA
0registered devices
8 including historic records
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
1active registrations
Class 3 1
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 Union86 raw hits, 15 excluded, 71 confirmed
United States13 registration records, 0 510(k), 0 PMA
United Kingdom5 confirmed, 0 excluded
Manufacturer names merged into this page: BEIJING HOTGEN BIOTECH CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000015566
EU authorised representative
MedNet EC-REP GmbH
UK responsible person
Medimap Ltd

Company information

Country
China
City
Beijing
Website
www.hotgenbiotech.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiation TherapyBrachytherapy

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.

FDA listed device types

showing 8 of 13
Radioimmunoassay, Follicle-Stimulating Hormone 1Radioimmunoassay, Progesterone 1Radioimmunoassay, Immunoreactive Insulin 1Radioimmunoassay, Estradiol 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Radioimmunoassay, Human Growth Hormone 1Radioimmunoassay, C-Peptides Of Proinsulin 1Radioimmunoassay, Luteinizing Hormone 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06936700410099Ferritin test (Up-converting Phosphor Technology)IVD B
EU06936700408935Interferon-γ test (Chemiluminescence Immunoassay)IVD B
EU06936700408812One Step Syphilis Anti-TP Test (Colloidal Gold)IVD C
EU06936700408829One Step Syphilis Anti-TP Test (Colloidal Gold)IVD C
UK66416Monkeypox Virus Antigen Rapid TestIVD general
UK66370Monkeypox Virus Real-time PCR kitIVD general
UK65454Coronavirus (2019-nCoV)-Antigentest-IVD Devices for Self-Testing

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