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CITOTEST Labware Manufacturing CO., LTD.

China · Haimen Jiangsu

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Australia, Israel, 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

46listed device types

Class I 46Class II 0Class III 0

plus 46 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 14

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

5active ARTG entries

Class I 1IVD Class 1 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 3

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 States46 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil14 confirmed, 0 excluded

Manufacturer names merged into this page: CITOTEST Labware Manufacturing CO., LTD. · CITOTEST LABWARE MANUFACTURING CO., LTD.

FDA listed device types

showing 8 of 46

Thermocycler, Generic 1Container, Specimen, Sterile 1Container, Specimen Mailer And Storage, Sterile 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Microscope, Inverted Stage, Tissue Culture 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Hematoxylin Mayer'S 1Dish, Tissue Culture 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80927230005	FAMÍLIA SWAB PARA COLETA E TRANSPORTE DE AMOSTRAS CONTENDO MEIOS DE CU	Class I
BR	10379860073	SWAB PARA COLETA E TRANSPORTE DE AMOSTRAS COM MEIO CARY-BLAIR	Class I
BR	10379860074	SWAB PARA COLETA E TRANSPORTE DE AMOSTRAS COM MEIO AMIES	Class I

CITOTEST Labware Manufacturing CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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