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HART ENTERPRISES, INC.

USA · Sparta

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

9listed device types

Class I 5Class II 4Class III 0

plus 10 registration records and 4 510(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

pendingnot queried

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 States10 registration records, 4 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: HART ENTERPRISES, INC.

FDA 510(k) clearances by year

11988 · K881730

11989 · K885149

11991 · K913815

11993 · K921683

FDA listed device types

showing 8 of 9

Introducer, Catheter 1Dilator, Vessel, For Percutaneous Catheterization 1Endoscopic Injection Needle, Gastroenterology-Urology 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Catheter, Cholangiography 1Accessories, Catheter 1Needle, Aspiration And Injection, Disposable 1Needle, Aspiration And Injection, Reusable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K921683	PENCIL POINT SPINAL NEEDLE	1993-08-26
US	K913815	AUTOMATED BIOPSY DEVICE, MODIFICATION	1991-10-30
US	K885149	NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE	1989-01-26

HART ENTERPRISES, 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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