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DIAGNOSTICS FOR THE REAL WORLD, LTD.

USA · Sunnyvale
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
4listed device types
Class I 1Class II 2Class III 1
plus 4 registration records and 0 510(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
2active device licences
Class III 2
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 States4 registration records, 0 510(k), 0 PMA, 6 excluded
Brazil0 confirmed, 2 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: DIAGNOSTICS FOR THE REAL WORLD, LTD. · DIAGNOSTICS FOR THE REAL WORLD LTD.

Company information

Country
USA
City
Sunnyvale

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents 1Respiratory Specimen Nucleic Acid Sars-Cov-2 Test 1Container, Specimen, Non-Sterile 1Monitor,Test,Hiv-1 1

Registration details (sample)

MarketIdentifierNameClass / date
CA78491CHLAMYDIA RAPID TESTClass III
CA86727CHLAMYDIA RAPID TEST FOR MALE URINE SPECIMENS (PROFESSIONAL USE)Class III

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