HomeUSAMESA LABORATORIES, INC.

MESA LABORATORIES, INC.

USA · Lakewood
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 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
7listed device types
Class I 2Class II 5Class III 0
plus 25 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
4active device licences
Class II 4
12 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States25 registration records, 9 510(k), 0 PMA, 6 excluded
Brazil0 confirmed, 2 excluded
Canada4 confirmed, 1 excluded
Manufacturer names merged into this page: MESA LABORATORIES, INC. · Mesa Laboratories Bozeman Manufacturing Facility (Zoot) · MESA LABORATORIES INC.

Company information

Country
USA
City
Lakewood

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.

Business registration

Legal name
MESA LABORATORIES INC /CO/
CIK
0000724004
Registration status
Active
Listing status
Listed (MLAB)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12004
12005
12012
22013
12014
12015
12019
12020

FDA listed device types

Ph Buffer 1Tubing, Pressure And Accessories 1Subsystem, Water Purification 1Solution-Test Standard-Conductivity, Dialysis 1Indicator, Physical/Chemical Sterilization Process 1Meter, Conductivity, Non-Remote 1Indicator, Biological Sterilization Process 1

Registration details (sample)

MarketIdentifierNameClass / date
USK201765SmartHDM-510 System2020-09-02
USK191496TDS Standard Solution2019-08-05
USK150657Phoenix XL Dialysate Meter2015-09-21
CA65984PHOENIX DIALYSATE METERClass II
CA65986NEO-STAT+ DIALYSATE METERClass II
CA65987NEO-2 DIALYSATE METERClass II

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