HomeDenmarkVitrex Medical A/S

Vitrex Medical A/S

Denmark · Herlev · www.vitrexmg.com
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, United Kingdom, Brazil, Taiwan, 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
0UDI-DI device records
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
5registered device records
IVD A 5
BRBrazilANVISA
2registered devices
Class I 1Class II 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
3registrations
RURussiaRoszdravnadzor
3active registrations
Class 1 1Class 2a 2
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 States2 registration records, 0 510(k), 0 PMA
United Kingdom5 confirmed, 0 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: VITREX MEDICAL A/S

Regulatory identity

UK responsible person
Emergo Consulting (UK) Limited

Company information

Country
Denmark
City
Herlev
Website
www.vitrexmg.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassaysMicrobiology & infectious disease diagnosticsHematology & coagulationPoint-of-care & near-patient testingHome & self-testingMedical Devices & Clinical Equipment

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

Tube, Collection, Capillary Blood 1Hematocrit, Tube, Rack, Sealer, Holder 1

Registration details (sample)

MarketIdentifierNameClass / date
UK57891BLOOD GAS 125MM 220ul AmIVD A
UK57892BLOOD GAS 125MM 220ul EDTAIVD A
UK61388BLOOD GAS 100mm 175ulIVD A
BR80131489007LANCETADOR VITREX COMPACT EJECTClass I
BR80131480011LANCETAClass II

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