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GRIFOLS DIAGNOSTICS SOLUTIONS INC

USA

✓ 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

15listed device types

Class I 4Class II 8Class III 0unclassified 3

plus 19 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 11

25 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

5active device licences

Class III 1Class IV 4

14 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 States19 registration records, 0 510(k), 0 PMA, 10 excluded

Brazil11 confirmed, 9 excluded

Canada5 confirmed, 3 excluded

Manufacturer names merged into this page: Grifols Diagnostic Solutions Inc. · GRIFOLS DIAGNOSTIC SOLUTIONS INC. · GRIFOLS DIAGNOSTICS SOLUTIONS INC · Grifols Diagnostic Solutions Inc · GRIFOLS DIAGNOSTIC SOLUTIONS INC

FDA listed device types

showing 8 of 15

Data Acquisition Software 1Blood Establishment Computer Software And Accessories 1Quality Control For Molecular Immunohematology Tests 1Test, Hiv Detection 1System, Test, Automated Blood Grouping And Antibody 1Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening. 1Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus 1Kit, Quality Control For Blood Banking Reagents 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80134860255	PROCLEIX AUTO DETECT (Procleix Panther System)	Class I
BR	80134860293	Procleix Parasite Transport Medium	Class I
BR	80134860309	SysCheck	Class I
CA	76842	PROCLEIX NAT TRACKER SOFTWARE	Class IV
CA	77437	PROCLEIX ULTRIO ASSAY (DONOR SCREENING/CADAVERIC TESTING)	Class IV
CA	86968	PROCLEIX SP POOLING SOFTWARE AND INSTRUMENT SYSTEM	Class IV

GRIFOLS DIAGNOSTICS SOLUTIONS INC

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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