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Visionare, LLC

USA · Fort Myers

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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

14listed device types

Class I 12Class II 2Class III 0

plus 13 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

7 including historic records

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 States13 registration records, 1 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: VISIONARE LLC

FDA 510(k) clearances by year

12018 · K180204

FDA listed device types

showing 8 of 14

Instrument, Bending Or Contouring 1Template 1Pliers, Surgical 1Bit, Drill 1Forceps, General & Plastic Surgery 1Gauge, Depth 1Clamp 1Retractor 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180204	CranioMaxillofacial Fixation (CMF) System - CMF Visionare	2018-12-28
BR	80546720142	INSTRUMENTAL EM ALUMÍNIO VISIONARE	Class I
BR	80546720137	INSTRUMENTAL EM AÇO INOX VISIONARE	Class I
BR	80546720143	INSTRUMENTAL ATIVO EM AÇO INOX VISIONARE	Class I

Visionare, LLC

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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