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FHC, INC.

USA · Bowdoin

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 10 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

7listed device types

Class I 2Class II 5Class III 0

plus 18 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 2Class II 6

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

12 including historic records

TWTaiwanTFDA

15valid device licences

Class II 15

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS D 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

14active ARTG entries

Class I 4IIa 7Class Is (sterile) 3

HKHong KongMDACS

4valid listings

Class II 2Class IV 2

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 States18 registration records, 12 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: FHC, INC. · FHC, Inc · FHC, INC · FHC INC

FDA 510(k) clearances by year

12000

32001

12004

12007

12009

12010

12012

12018

12020

12023

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Surgical Planning Software For Neurological Stereotaxic Instruments 1Holder, Head, Neurosurgical (Skull Clamp) 1Neurological Stereotaxic Instrument 1Electrode, Depth 1Stylet, Surgical, General & Plastic Surgery 1Instrument, Surgical, Non-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231141	STarFix Designer Software C0265	2023-09-08
US	K200169	VFS1 Bipolar Electrosurgical Generator	2020-05-14
US	K183123	microTargeting Guideline 4000 5.0 System	2018-12-20
BR	10349000663	MicroTargeting Star Drive	Class I
BR	10349000721	Cânula de Inserção para eletrodo com mandril e 5 pct para Estereotaxia	Class II
BR	10349000738	Cânula de Inserção para eletrodo único 5 pct para Nexframe e STar Driv	Class II
SA	ME0000004856SFDAA00038	microTargeting™	—
CA	27800	MICROTARGETING DRIVE SYSTEM	Class II

FHC, 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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