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FLEXBAR MACHINE CORP.

USA · Islandia

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Australia — 4 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

26listed device types

Class I 17Class II 9Class III 0

plus 27 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

41registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 2

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 6

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 States27 registration records, 2 510(k), 0 PMA

Saudi Arabia41 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: FLEXBAR MACHINE CORP. · MEDIFLEX, A DIVISION OF FLEXBAR MACHINE CORPORATION · Mediflex, Div. of Flexbar Machine Corp.

FDA 510(k) clearances by year

12011 · K103840

12013 · K123728

FDA listed device types

showing 8 of 26

Instrument, Ligature Passing And Knot Tying 1Retractor, Fiberoptic 1Support, Patient Position 1Catheter, Cholangiography 1Retractor, Self-Retaining 1Applier, Surgical, Clip 1Gag, Mouth 1Clamp 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K123728	RETRIEVAL BAG	2013-12-11
US	K103840	CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE	2011-02-28
SA	ME0000019390SFDAA00002	Nathanson Retractor	—
SA	ME0000019420SFDAA00015	Bookler Endo FlexArm Plus Sys	—
CA	69050	WEISS RETINAL MICROCANNULA	Class II
CA	98396	FLEXGUARD RETRACTOR BLADE CUSHION	Class II

FLEXBAR MACHINE CORP.

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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