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Huestis Machine Corporation

USA · Bristol

✓ 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

13listed device types

Class I 4Class II 9Class III 0

plus 15 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

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 States15 registration records, 7 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: HUESTIS MACHINE CORP.

FDA 510(k) clearances by year

11980 · K792721

11988 · K880047

21990 · K904005

11994 · K926187

11995 · K940145

12018 · K181874

FDA listed device types

showing 8 of 13

System, Applicator, Radionuclide, Remote-Controlled 1System, Therapeutic, X-Ray 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1System, Simulation, Radiation Therapy 1Accelerator, Linear, Medical 1Block, Beam-Shaping, Radiation Therapy 1Cassette, Radiographic Film 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K181874	MX40 Mobile Digital X-ray System	2018-09-14
US	K940145	COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE	1995-01-24
US	K926187	POSICAST IMMOBILIZATION SYSTEM	1994-04-15

Huestis Machine Corporation

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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