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3D MEDICAL APPLICATIONS CENTER (3D MAC)

USA · Bethesda

✓ 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 2 510(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, 2 510(k), 0 PMA, 8 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.

FDA 510(k) clearances by year

12008 · K080609

12019 · K180842

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)

Market	Identifier	Name	Class / date
US	K180842	MAC Medical D-Series Blanket and Solution Warming Cabinets	2019-03-05
US	K080609	SWC/DWC WARMING CABINETS	2008-06-13
SA	ME0000001172SFDAA00007	Dual Chamber Warming Cabinet	—

3D MEDICAL APPLICATIONS CENTER (3D MAC)

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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