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DIAGNOSTIC GRIFOLS, S.A.

Spain · Parets Del Valles

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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

17listed device types

Class I 5Class II 9Class III 0unclassified 3

plus 30 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class I 7Class II 9

52 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

20 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

17device registrations

CLASS C 3CLASS D 14

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

10active ARTG entries

IVD Class 1 4IVD Class 2 1IVD Class 3 2IVD Class 4 3

HKHong KongMDACS

8valid listings

IVD C 1IVD D 7

ILIsraelAMAR

10registrations

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 States30 registration records, 1 510(k), 0 PMA, 8 excluded

Brazil16 confirmed, 5 excluded

Canada5 confirmed, 2 excluded

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

FDA 510(k) clearances by year

12019 · K183390

FDA listed device types

showing 8 of 17

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 1Manual Blood Grouping And Antibody Test Systems 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K183390	QNext and DG-PT	2019-08-21
BR	80134860100	DG GEL SOL	Class I
BR	80134860165	DG READER	Class II
BR	10364120050	AUTOANALISADOR PARA IMUNOHEMATOLOGIA WADIANA COMPACT	Class II
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

DIAGNOSTIC GRIFOLS, S.A.

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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