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Mci Medical Concept Innovation, Inc.

USA · Sunrise

✓ 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

13listed device types

Class I 8Class II 5Class III 0

plus 10 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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 States10 registration records, 2 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 1 excluded

Manufacturer names merged into this page: MCI MEDICAL CONCEPT INNOVATION INC.

FDA 510(k) clearances by year

12019 · K182758

12022 · K212391

FDA listed device types

showing 8 of 13

Tray, Surgical, Needle 1Motor, Surgical Instrument, Pneumatic Powered 1Retractor, All Types 1Instrument, Manual, Surgical, General Use 1Pliers, Operative 1Tray, Surgical, Instrument 1Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212391	MCI-Neuro Fixation System	2022-10-21
US	K182758	MCI - CMF System	2019-12-05
BR	81529699002	MCI - TMJ Cannulated Arthroscopy	Class II
BR	81529699003	MCI - TMJ CANNULATED ADVANCED SUTURE	Class II
BR	81529690003	MCI-CRANIOMAXILLOFACIAL INSTRUMENT SET	Class I

Mci Medical Concept Innovation, 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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