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QINGDAO HIGHTOP BIOTECH CO., LTD.

China · Qingdao Shandong

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, South Korea, Australia, 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

pendingnot queried

USUnited StatesFDA openFDA

14listed device types

Class I 2Class II 11Class III 0unclassified 1

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

53registered devices

Class II 53

98 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

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 2 2

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.

United States5 registration records, 3 510(k), 0 PMA

Brazil53 confirmed, 0 excluded

Manufacturer names merged into this page: QINGDAO HIGHTOP BIOTECH CO., LTD. · QINGDAO HIGHTOP BIOTECH CO.,LTD. · QINGDAO HIGHTOP BIOTECH CO., LTD · QINGDAO HIGHTOP BIOTECH CO. LTD.

FDA 510(k) clearances by year

12019 · K192123

12022 · K220685

12024 · K241969

FDA listed device types

showing 8 of 14

Test, Barbiturate, Over The Counter 1Test, Methamphetamine, Over The Counter 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Test, Opiates, Over The Counter 1Test, Benzodiazepine, Over The Counter 1Test, Amphetamine, Over The Counter 1Test, Cannabinoid, Over The Counter 1Test, Cocaine And Cocaine Metabolites, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241969	Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel	2024-08-14
US	K220685	HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx	2022-05-05
US	K192123	HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream	2019-09-05
BR	80258020031	HCG SORO/URINA	Class II
BR	80258020032	HCG SORO/URINA 10mUI	Class II
BR	80474870175	Analisador Automatizado de Imunoensaio por Fluorescência Luminis Pro	Class II

QINGDAO HIGHTOP BIOTECH CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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