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SSI Diagnostica A/S

Denmark · Hilleroed

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel, Russia — 6 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

11listed device types

Class I 8Class II 3Class III 0

plus 11 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

1 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 1 1IVD Class 3 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States11 registration records, 1 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: SSI Diagnostica A/S · SSI DIAGNOSTICA A/S

FDA 510(k) clearances by year

12020 · K191184

FDA listed device types

showing 8 of 11

Antisera, All Groups, Streptococcus Spp. 1Antigens, All Types, Escherichia Coli 1Reagents, Specific, Analyte 1Antisera, All Types, Escherichia Coli 1Antisera, All Types, Streptococcus Pneumoniae 1Culture Media, Selective And Differential 1Antigens, All Groups, Streptococcus Spp. 1Kit, Identification, Dermatophyte 1

SSI Diagnostica A/S

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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