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CENTER HEALTH INC.

USA · Hillsborough

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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

16listed device types

Class I 9Class II 7Class III 0

plus 17 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

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

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 States17 registration records, 11 510(k), 0 PMA, 184 excluded

Brazil2 confirmed, 14 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada0 confirmed, 6 excluded

Manufacturer names merged into this page: CARESTREAM HEALTH, INC., GLOBAL R&D CENTER · COMPASS HEALTH BRANDS (DISTRIBUTION CENTER) · CENTER HEALTH INC. · 3M Health Care / 3M Center

FDA 510(k) clearances by year

11978

21993

12004 · K043332

72005 · K052558

FDA listed device types

showing 8 of 16

Holder, Radiographic Cassette, Wall-Mounted 1Stand, Infusion 1Generator, High-Voltage, X-Ray, Diagnostic 1Set, Tubing And Support, Ventilator (W Harness) 1Continuous Glucose Monitor Retrospective Data Analysis Software 1Tubing, Pressure And Accessories 1Yoke Assembly, Medical Gas 1Mattress And Bed Deck Cover (Medical Purposes) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K052558	VCS, MODEL S4T	2005-10-27
US	K051130	VCS S3Y	2005-09-09
US	K051131	VCS S3T	2005-08-15
BR	80284930285	CURATIVOS PARA OS PÉS 3M NEXCARE	Class I
BR	80284930271	CURATIVOS SUPERFLEXÍVEIS 3M NEXCARE	Class I

CENTER HEALTH INC.

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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