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Diversatek Healthcare, Inc.

USA · Highlands Ranch

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 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

38listed device types

Class I 10Class II 28Class III 0

plus 44 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 5Class II 7

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

11active device licences

Class II 11

39 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States44 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil12 confirmed, 0 excluded

Canada11 confirmed, 0 excluded

Manufacturer names merged into this page: DIVERSATEK HEALTHCARE INC · DIVERSATEK HEALTHCARE INC. · DIVERSATEK HEALTHCARE · DIVERSATEK HEAL THCARE

FDA 510(k) clearances by year

22019 · DEN180067

12022 · K222734

12023 · K230056

FDA listed device types

showing 8 of 38

Forceps, Biopsy, Non-Electric 1Retractor, Fiberoptic 1Accessories, Cleaning Brushes, For Endoscope 1Catheter, Ventricular, General & Plastic Surgery 1Electrode, Ph, Stomach 1Endoscopic Bite Block 1Tray, Biopsy, Without Biopsy Instruments 1Snare, Non-Electrical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230056	MiVu Esophageal Endo Cap	2023-04-25
US	K222734	Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing	2022-11-08
US	DEN180067	Mucosal Integrity Conductivity (MI) Test System	2019-12-23
BR	10368419015	DILATADORES ESOFÁGICOS (BOUGIES SAVARY) E ACESSÓRIOS	Class II
BR	80807439013	Ponta de Fibra Óptica InnerVision®	Class II
BR	80807439014	Cabo de Fibra Óptica InnerVision	Class II
CA	1468	BIOLAB MANOMETRY SYSTEM	Class II
CA	62228	BIOLAB MANOMETRY SYSTEM	Class II
CA	2616	INSIGHT MANOMETRY SYSTEM	Class II

Diversatek Healthcare, 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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