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BREG, INC.

USA · Carlsbad

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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

33listed device types

Class I 30Class II 3Class III 0

plus 67 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

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

12active device licences

Class II 12

18 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 10IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States67 registration records, 16 510(k), 0 PMA, 2 excluded

Brazil2 confirmed, 0 excluded

Canada12 confirmed, 0 excluded

Manufacturer names merged into this page: BREG, INC., · BREG, INC.

FDA 510(k) clearances by year

31991

11992

11995

21996

11998

32000

12001

12002

12004

12007

12019

FDA listed device types

showing 8 of 33

Sling, Arm, Overhead Supported 1Cushion, Flotation 1Orthosis, Lumbar 1Splint, Hand, And Components 1Insoles, Medical 1Crutch 1Orthosis, Limb Brace 1Orthosis, Abdominal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K183702	Polar Care Wave	2019-03-01
US	K070402	MODIFICATION TO POLAR CARE 500	2007-03-29
US	K041714	E-PAIN CARE	2004-10-01
BR	80102512241	IMOBILIZADORES ORTOPÉDICOS GENESIS	Class I
BR	80102512286	Tensores de Suporte	Class I
CA	13311	PAIN CARE 2000	Class II
CA	30618	PAIN CARE 3000	Class II
CA	37357	PAIN CARE 3200/4200	Class II

BREG, 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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