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MEDI-GLOBE BRASIL LTDA

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

5listed device types

Class I 0Class II 5Class III 0

plus 21 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

52registered devices

Class I 13Class II 39

68 including historic records

SASaudi ArabiaSFDA

10registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

32 including historic records

TWTaiwanTFDA

20valid device licences

Class II 20

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIa 2

HKHong KongMDACS

4valid listings

Class II 1Class III 3

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 States21 registration records, 26 510(k), 0 PMA, 6 excluded

Brazil52 confirmed, 0 excluded

Saudi Arabia10 confirmed, 1 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: MEDI-GLOBE GMBH · MEDI-GLOBE SRO · MEDI-GLOBE, GMBH · MEDI GLOBE GMBH · MEDI-GLOBE BRASIL LTDA · Medi-Globe GmbH

FDA 510(k) clearances by year

11990

41994

51995

21996

11999

12002

22003

12005

22006

12007

22009

22014

12016

12026

FDA listed device types

Biopsy Needle 1Endoscopic Injection Needle, Gastroenterology-Urology 1Bottle, Collection, Vacuum 1Snare, Flexible 1Stents, Drains And Dilators For The Biliary Ducts 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251658	Endoflux Biliary & Pancreatic Stent Sets	2026-04-16
US	K153264	EasyPass Guidewire	2016-05-19
US	K142258	PolyCatch Retrieval Device	2014-09-30
BR	80073119003	PINÇA PARA RETIRADA DE CORPO ESTRANHO	Class II
BR	80073119001	PINÇA DE BIÓPSIA	Class II
BR	80073119002	INJETOR ENDOSCÓPICO	Class II
SA	ME0000006494SFDAA00010	Bite Block	—
SA	ME0000006494SFDAA00001	ReBite	—
CA	74097	SONOTIP II ULTRASONIC NEEDLE SYSTEM	Class II
CA	80240	SONOTIP II EBUS-TBNA NEEDLE SYSTEM	Class II
CA	89998	INFLATION SYSTEM	Class II

MEDI-GLOBE BRASIL LTDA

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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