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Home›Norway›ABBOTT DIAGNOSTIC TECHNOLOGIES AS

ABBOTT DIAGNOSTIC TECHNOLOGIES AS

Norway · Oslo
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
11listed device types
Class I 7Class II 4Class III 0
plus 7 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
14registered devices
Class II 14
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
5 including historic records
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 States7 registration records, 1 510(k), 0 PMA, 66 excluded
Brazil14 confirmed, 29 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 30 excluded
Manufacturer names merged into this page: Abbott Diagnostics Technologies AS · ABBOTT DIAGNOSTIC TECHNOLOGIES AS · ABBOTT DIAGNOSTICS TECHNOLOGIES AS
Same-named companies — This database also contains companies with near-identical names: Abbott Diagnostics Technologies AS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Norway
City
Oslo

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 510(k) clearances by year

12023 · K214117

FDA listed device types

showing 8 of 11
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica 1Enzymatic Esterase--Oxidase, Cholesterol 1Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) 1Multi-Analyte Controls, All Kinds (Assayed) 1Ldl & Vldl Precipitation, Hdl 1Colorimetric Method, Triglycerides 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Hemoglobin A1c Test System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer2023-09-27
BR10071770755NycoCard U-AlbuminaClass II
BR10071770868Afinion HbA1cClass II
BR10071770869Afinion HbA1c ControleClass II

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