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MEDONE SURGICAL, INC.

USA · Sarasota

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

11listed device types

Class I 10Class II 1Class III 0

plus 11 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 1Class II 5

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

1active device licences

Class II 1

6 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States11 registration records, 1 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: MEDONE SURGICAL, INC. · MEDONE SURGICAL INC. · MedOne Surgical, Inc.

FDA 510(k) clearances by year

12021 · K203264

FDA listed device types

showing 8 of 11

Cannula, Trocar, Ophthalmic 1Knife, Ophthalmic 1Spatula, Ophthalmic 1Kit, Surgical Instrument, Disposable 1Cannula, Ophthalmic 1Scissors, Ear 1Forceps, Ophthalmic 1Needle, Aspiration And Injection, Disposable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203264	MicroDose Injector	2021-04-26
BR	80170280087	MicroDose TM Injection	Class I
BR	80122640030	Cânulas Blackflush Passiva MedOne	Class II
BR	80122640031	Cânulas de Infusão MedOne	Class II
CA	102562	OPHTHALMIC FORCEPS	Class II

MEDONE SURGICAL, 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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