HomeUSAHEMO BIOSCIENCE INC.

HEMO BIOSCIENCE INC.

USA · Durham
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Taiwan — 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
8listed device types
Class I 3Class II 5Class III 0
plus 11 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
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
TWTaiwanTFDA
2valid device licences
Class I 2
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 States11 registration records, 0 510(k), 0 PMA, 3 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: HEMO BIOSCIENCE · HEMO BIOSCIENCE INC.

Company information

Country
USA
City
Durham

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

Diluent, Blood Cell 1Reagents, Specific, Analyte 1Whole Human Serum, Antigen, Antiserum, Control 1Media, Potentiating For In Vitro Diagnostic Use 1Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use 1Lectins And Protectins 1Solution, Stabilized Enzyme 1Kit, Quality Control For Blood Banking Reagents 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81246986915ELUclear KitClass I

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