Home›USA›Greiner America, Inc.

Greiner America, Inc.

USA · Wilmington

✓ 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

5listed device types

Class I 1Class II 4Class III 0

plus 20 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

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 States20 registration records, 27 510(k), 0 PMA, 7 excluded

Brazil3 confirmed, 5 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: GREINER BIO-ONE NORTH AMERICA, INC. · GREINER VACUETTE NORTH AMERICA INC.

FDA 510(k) clearances by year

31996

41997

12000

42001

12002

22003

12005

12006

22007

22008

22010

22012

12013

12024

FDA listed device types

Blood/Plasma Collection Device For Dna Testing 1Tubes, Vacuum Sample, With Anticoagulant 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1Needle, Hypodermic, Single Lumen 1Container, Specimen, Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233979	VACUETTE® QUICKSHIELD Complete (Plus)	2024-07-19
US	K122687	BLOOD CULTURE HOLDER	2013-01-10
US	K121908	SAFETY INFUSION SET	2012-07-25
BR	10290310037	TUBO PARA COLETA DE SANGUE A VACUO VACUETTE	Class I
BR	10290310032	VACUETTE TUBO PARA COLETA DE SANGUE A VÁCUO COM ANTICOAGULANTE	Class I
BR	10290310034	FAMÍLIA VACUETTE TUBO PARA COLETA A VÁCUO PARA SOROLOGIA	Class I

Greiner America, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies