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GREINER BIO-ONE BRASIL PRODUTOS MÉDICOS HOSPITALARES LTDA

Brazil

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

16listed device types

Class I 10Class II 6Class III 0

plus 92 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

33registered devices

Class I 23Class II 10

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

3active device licences

Class II 3

9 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 States92 registration records, 20 510(k), 0 PMA, 5 excluded

Brazil33 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada3 confirmed, 1 excluded

Manufacturer names merged into this page: GREINER BIO-ONE GMBH · GREINER BIO-ONE HUNGARY KFT · GREINER BIO ONE BRASIL PRODUTOS MEDICOS HOSPITALAR · GREINER BIO-ONE NORTH AMERICA, INC. · GREINER BIO ONE GMBH · GREINER BIO-ONE (THAILAND) LTD

Same-named companies — This database also contains companies with near-identical names: GREINER BIO-ONE GMBH, GREINER BIO ONE BRASIL PRODUTOS MEDICOS HOSPITALAR, GREINER BIO-ONE NORTH AMERICA, INC., GREINER BIO-ONE (THAILAND) LTD. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12001

22003

12005

12006

22007

22008

22010

22012

12013

12016

12017

22018

12019

12024

FDA listed device types

showing 8 of 16

Tubes, Vacuum Sample, With Anticoagulant 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Blood/Plasma Collection Device For Dna Testing 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1Transport Medium, Notified Per The Vtm Guidance 1Container, Specimen, Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233979	VACUETTE® QUICKSHIELD Complete (Plus)	2024-07-19
US	K182078	MiniCollect K2E K2EDTA Tubes	2019-01-25
US	K180545	VACUETTE SAFELINK Holder with male luer lock	2018-05-21
BR	10290310013	AGULHA MÚLTIPLA PARA COLETA DE SANGUE A VACUO VACUETTE	Class II
BR	10290310046	VACUETTE QUICKSHIELD COMPLETE	Class II
BR	10290319010	ADAPTADOR PARA TRANSFERÊNCIA DE SANGUE VACUETE	Class II
CA	84645	SED RATE ANALYZERS	Class II
CA	86721	VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH	Class II
CA	96996	MINICOLLECT LANCELINO SAFETY LANCETS	Class II

GREINER BIO-ONE BRASIL PRODUTOS MÉDICOS HOSPITALARES 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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