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Medical Innovation , Ltd.

USA · Washington

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Hong Kong — 6 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

21listed device types

Class I 13Class II 7Class III 0unclassified 1

plus 19 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

98registered devices

Class I 52Class II 46

126 including historic records

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

7active device licences

Class II 5Class III 2

10 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class II 1

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 States19 registration records, 13 510(k), 0 PMA, 86 excluded

Brazil98 confirmed, 16 excluded

Saudi Arabia2 confirmed, 3 excluded

Canada7 confirmed, 15 excluded

Manufacturer names merged into this page: MCI MEDICAL CONCEPT INNOVATION INC. · Sinolinks Medical Innovation, Inc. · HEFEI BOX MEDICAL INNOVATION CO., LTD · AVANT-GARDE MEDICAL INNOVATION · INVERNESS MEDICAL INNOVATION, INC. · MEDICAL INNOVATION DEVELOPPEMENT SAS

FDA 510(k) clearances by year

11998

12007

22013

12014

22015

12016

12019

12020

12021

12022

12025

FDA listed device types

showing 8 of 21

Template 1Tray, Surgical, Needle 1Motor, Surgical Instrument, Pneumatic Powered 1Applier, Surgical, Clip 1Instrument, Surgical, Disposable 1Retractor, All Types 1Instrument, Manual, Surgical, General Use 1Pliers, Operative 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250820	Disposable Trocars	2025-07-11
US	K212391	MCI-Neuro Fixation System	2022-10-21
US	K202521	PtoleMedic System	2021-05-04
BR	80082910063	INSTRUMENTAIS DE PEQUENOS E GRANDES FRAGMENTOS	Class I
BR	80082910059	FIXADOR EXTERNO EASY FIX GRANDE	Class I
BR	80082910060	FIXADOR EXTERNO EASY FIX MINI	Class I
SA	ME0000015294SFDAA00002	Suprapatellar Instruments Set	—
SA	ME0000015294SFDAA00003	Standard Instruments Set with Distal Aiming Device	—
CA	28000	THIN LANCETS	Class II
CA	30538	BLOOD GLUCOSE TEST STRIPS G	Class III
CA	61252	MIDAIG AIGUILLE DE HUBER	Class II

Medical Innovation , Ltd.

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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