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Vital Signs Colorado, Inc.

USA · Englewood

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 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

2listed device types

Class I 1Class II 1Class III 0

plus 2 registration records and 79 510(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

6active device licences

Class I 1Class II 5

7 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class Is (sterile) 1

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 States2 registration records, 79 510(k), 0 PMA

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: Shenzhen Vital Signs-KTL Medical Instrument Co Ltd · CNS VITAL SIGNS · VITAL SIGNS, INC. A GE HEALTHCARE COMPANY · VITAL SIGNS, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243183	RTMsense Respiratory Monitoring System	2025-06-27
US	K130867	ENFLOW IV FLUID WARMER INSULATED STRAP	2013-06-14
US	K121775	ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER	2012-11-28
CA	68981	C-CO2 COLORIMETRIC CO2 INDICATOR	Class II
CA	21487	INFUSABLE PRESSURE INFUSORS	Class I
CA	22683	NASAL CANNULA	Class II

Vital Signs Colorado, 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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