HomeGermanyaltona Diagnostics GmbH

altona Diagnostics GmbH

Germany · Hamburg
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
9registered devices
Class I 3Class II 6
51 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
12 including historic records
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
3device registrations
CLASS B 1CLASS C 1CLASS D 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
5active ARTG entries
IVD Class 1 1IVD Class 2 2IVD Class 3 2
HKHong KongMDACS
5valid listings
IVD B 1IVD C 4
ILIsraelAMAR
8registrations
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 States2 registration records, 0 510(k), 0 PMA
Brazil9 confirmed, 0 excluded
Manufacturer names merged into this page: altona Diagnostics GmbH · ALTONA DIAGNOSTICS GMBH · ALTONA DIAGNOSTICS BRASIL LTDA
Same-named companies — This database also contains companies with near-identical names: ALTONA DIAGNOSTICS BRASIL LTDA. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Germany
City
Hamburg

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

General Purpose Reagent 1Reagents, Specific, Analyte 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81752180008AltoStar® Internal Control 1.5 (IC15-46)Class II
BR81752180009AltoStar® Purification Kit 1.5 (PK15-46)Class I
BR81752180032AltoStar Pneumocystis jirovecii PCR Kit 1.5Class II

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