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Home›USA›Nantong Biotechnology Co., Ltd.

Nantong Biotechnology Co., Ltd.

USA · Gaithersburg
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
7listed device types
Class I 2Class II 5Class III 0
plus 6 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
14 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
4 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
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.

United States6 registration records, 2 510(k), 0 PMA, 28 excluded
Brazil2 confirmed, 7 excluded
Saudi Arabia0 confirmed, 4 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: NANTONG EGENS BIOTECHNOLOGY CO.,LTD. · NANTONG EGENS BIOTECHNOLOGY CO., LTD. · NANTONG EGENS BIOTECHNOLOGY CO.,LTD · NANTONG EGENS BIOTECHNOLOGY
Same-named companies — This database also contains companies with near-identical names: Nantong Egens Biotechnology Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Gaithersburg

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 510(k) clearances by year

12013 · K123050
12024 · K232864

FDA listed device types

Visual, Pregnancy Hcg, Prescription Use 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Thin Layer Chromatography, Morphine 1Gas Chromatography, Methamphetamine 1Enzyme Immunoassay, Cannabinoids 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Test, Luteinizing Hormone (Lh), Over The Counter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232864EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II2024-01-26
USK123050EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)2013-02-05
BR81464750107Teste de GravidezClass II
BR80258020062FAST TEST GRAVIDEZ SEMANASClass II
CA96636EASY1STEP DOA TESTClass II

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