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CROSSTEX INTERNATIONAL, INC.

USA · Rush

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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

33listed device types

Class I 25Class II 8Class III 0

plus 66 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

5 including historic records

TWTaiwanTFDA

7valid device licences

Class I 2Class II 5

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

11active registrations

Class 1 10Class 2a 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 States66 registration records, 7 510(k), 0 PMA, 3 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Crosstex International · CROSSTEX INTERNATIONAL, INC. · Crosstex International Inc.,

FDA 510(k) clearances by year

12008 · K082258

12010 · K103303

12011 · K111343

32014 · K140566

12021 · K200096

FDA listed device types

showing 8 of 33

Evacuator, Oral Cavity 1Unit, Operative Dental 1Handpiece, Belt And/Or Gear Driven, Dental 1Instrument, Contouring, Matrix, Operative 1Bedding, Disposable, Medical 1Chair, Dental, Without Operative Unit 1Unit, Syringe, Air And/Or Water 1Absorber, Saliva, Paper 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200096	Crosstex VH2O2 Chemical Indicators	2021-07-15
US	K140566	SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE	2014-11-24
US	K140620	SPORVIEW PLUS BI TEST PACK	2014-08-07
SA	ME0000012013SFDAA00002	ARTICULATING PAPER	—
CA	67041	NITRILE EXAM GLOVES	Class II

CROSSTEX INTERNATIONAL, INC.

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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