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KENTEC MEDICAL, INC.

USA · Irvine

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Israel — 2 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

12listed device types

Class I 7Class II 5Class III 0

plus 14 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States14 registration records, 6 510(k), 0 PMA

Manufacturer names merged into this page: KENTEC MEDICAL, INC.

FDA 510(k) clearances by year

11985 · K853475

11996 · K960080

11997 · K970686

12005 · K050443

12010 · K100526

12012 · K120272

FDA listed device types

showing 8 of 12

Dispenser, Liquid Medication 1Utensil, Eating 1Splint, Extremity, Non-Inflatable, External, Non-Sterile 1System, Blood Collection, Vacuum-Assisted, Manual 1Applicator, Absorbent Tipped, Non-Sterile 1Supplies, Blood-Bank 1Tape And Bandage, Adhesive 1Tube, Feeding 1

Market	Identifier	Name	Class / date
US	K120272	AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET	2012-02-17
US	K100526	AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE	2010-04-22
US	K050443	ACCU-LEAD	2005-09-02

KENTEC MEDICAL, 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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