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B C Medical , Ltd.

Canada

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

47listed device types

Class I 21Class II 26Class III 0

plus 73 registration records and 42 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

4 including historic records

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 States73 registration records, 42 510(k), 0 PMA, 8,874 excluded

Brazil0 confirmed, 2,572 excluded

Saudi Arabia0 confirmed, 968 excluded

Canada1 confirmed, 1,237 excluded

Manufacturer names merged into this page: B & J Medical LLC · I.C. MEDICAL, INC.

FDA 510(k) clearances by year

21980

11981

11987

11989

21990

21992

51993

51994

31995

51996

12000

12001

12007

22008

12009

12011

12013

52014

12016

12017

FDA listed device types

showing 8 of 47

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Probe 1Chisel, Surgical, Manual 1Impactor 1Table, Surgical With Orthopedic Accessories, Manual 1Guide, Surgical, Instrument 1Screwdriver 1Driver, Surgical, Pin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K163659	Crystal Vision	2017-10-30
US	K160160	Non-Telescopic PenEvac	2016-04-05
US	K140428	ULTRASOUND SCANNER SYSTEM BK2300	2014-05-30
CA	87765	CRYSTAL VISION-MODEL 360	Class II

B C Medical , 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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