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Mac Medical, Inc.

USA · Millstadt
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 2 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
6listed device types
Class I 2Class II 4Class III 0
plus 5 registration records and 16 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
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 States5 registration records, 16 510(k), 0 PMA, 7 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: MAC MEDICAL · 3D MEDICAL APPLICATIONS CENTER (3D MAC) · Mac Medical Inc.
Same-named companies — This database also contains companies with near-identical names: 3D MEDICAL APPLICATIONS CENTER (3D MAC). Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Millstadt

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

11979
11983
21984
71986
21987
11988
12008
12019

FDA listed device types

Warmer, Thermal, Infusion Fluid 1Stretcher, Wheeled 1Plate, Cranioplasty, Preformed, Alterable 1Plate, Cranioplasty, Preformed, Non-Alterable 1Stand, Infusion 1Warmer, Irrigation Solution 1

Registration details (sample)

MarketIdentifierNameClass / date
USK180842MAC Medical D-Series Blanket and Solution Warming Cabinets2019-03-05
USK080609SWC/DWC WARMING CABINETS2008-06-13
USK872953DISPOSABLE I.V. ADMINISTRATION SET1988-01-06
SAME0000001172SFDAA00007Dual Chamber Warming Cabinet—

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