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PROGENIKA BIOPHARMA S.L.

Spain

✓ 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

5listed device types

Class I 0Class II 4Class III 1

plus 5 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 1Class II 9

13 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

15 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 States5 registration records, 4 510(k), 0 PMA

Brazil10 confirmed, 0 excluded

Manufacturer names merged into this page: PROGENIKA BIOPHARMA S.A. · PROGENIKA BIOPHARMA S.L.

Same-named companies — This database also contains companies with near-identical names: PROGENIKA BIOPHARMA S.A., Progenika Biopharma S.A., A Grifols Company. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12017 · K171868

12019 · K192858

12021 · K211115

12022 · K221420

FDA listed device types

Serpina1 Variant Detection System 1Genetic Variant Detection And Health Risk Assessment System 1Dna Specimen Collection, Saliva 1Quality Control For Molecular Immunohematology Tests 1Molecular Erythrocyte Typing Test 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221420	AlphaID At Home Genetic Health Risk Service	2022-10-27
US	K211115	A1AT Genotyping Test	2021-05-13
US	K192858	A1AT Genotyping Test	2019-11-05
BR	80134860235	PROMONITOR ANTI-ADL	Class II
BR	80134860239	PROMONITOR ANTI-IFX	Class II
BR	80134860242	PROMONITOR IFX	Class II

PROGENIKA BIOPHARMA S.L.

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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