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Globe Scientific

USA · Mahwah NJ · www.globescientific.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN NL-MF-000046521

This company has registrations in European Union, United States, Israel — 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

40UDI-DI device records

IVD A 40

USUnited StatesFDA openFDA

41listed device types

Class I 39Class II 2Class III 0

plus 41 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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.

European Union50 raw hits, 10 excluded, 40 confirmed

United States41 registration records, 0 510(k), 0 PMA, 10 excluded

United Kingdom0 confirmed, 2 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: GLOBE SCIENTIFIC, LLC

Regulatory identity

EU manufacturer SRN: NL-MF-000046521

FDA listed device types

showing 8 of 41

Container, Specimen Mailer And Storage, Sterile 1Container, Specimen, Sterile 1Test, Erythrocyte Sedimentation Rate 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Analyzer, Chemistry, Micro, For Clinical Use 1Cassettes, Tissue 1Slides, Microscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00840095608428	Centrifuge, Hematocrit, 24-Place	IVD A
EU	00840095681674	Centrifuge, Clinical, Portable	IVD A
EU	00840095670616	Centrifuge, Clinical, Multi-Purpose, 240V	IVD A
EU	00840095608398	Centrifuge, Clinical, Standard	IVD A

Globe Scientific

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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