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Abbott Laboratories de Mexico

Mexico · Cuautitlan Izcalli Mexico
✓ 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
199listed device types
Class I 54Class II 138Class III 3unclassified 4
plus 394 registration records and 889 510(k), 702 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
49registered devices
Class I 26Class II 23
51 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
12 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 States394 registration records, 889 510(k), 702 PMA, 63 excluded
Brazil49 confirmed, 29 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada1 confirmed, 30 excluded
Manufacturer names merged into this page: ABBOTT LABORATORIES · Abbott Laboratories de Mexico · Abbott Medical Mexico, S. de R.L. de C.V.

Company information

Country
Mexico
City
Cuautitlan Izcalli Mexico

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

92006
22007
42008
32009
22010
82011
72012
32013
12014
72015
22016
62017
22018
12019
12021
32022
72023
12024
32025
12026

FDA listed device types

showing 8 of 199
Counter, Differential Cell 1Igm, Antigen, Antiserum, Control 1Turbidimetric, Total Protein 1Enzyme Immunoassay, Benzodiazepine 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Cardiac C-Reactive Protein, Antigen, Antiserum, And Control 1Catheter, Intracardiac Mapping, High-Density Array 1Calibrator For Hemoglobin And Hematocrit Measurement 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252424Anti-HCV Next2026-04-28
USK243500ARCHITECT iGentamicin2025-07-09
USK243168Alinity i Rubella IgG2025-06-20
BR10055310785WBC REAGENT PART BClass I
BR10055310787WBC REAGENT PART AClass I
BR10055311064ARCHITECT TSH CALIBRATORS / ARCHITECT TSH CALIBRATORESClass II
CA61397FLEXIFLO ENTERAL FEEDING TUBESClass II

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