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ZOE MEDICAL, INCORPORATED

USA · Topsfield

✓ Record-verifiedregistrations found in 3 markets

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

5listed device types

Class I 0Class II 5Class III 0

plus 7 registration records and 5 510(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

2active device licences

Class III 2

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States7 registration records, 5 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: ZOE MEDICAL, INC. · ZOE MEDICAL, INCORPORATED

FDA 510(k) clearances by year

12001 · K001775

12004 · K040012

12010 · K093802

12013 · K130740

12021 · K200160

FDA listed device types

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) 1System, Measurement, Blood-Pressure, Non-Invasive 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Oximeter 1Electrocardiograph 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200160	740 SafeSAT	2021-02-15
US	K130740	NIGHTINGALE MONITORING SYSTEM	2013-07-23
US	K093802	ULTRAVIEW DM3 MONITOR	2010-04-09
CA	62722	740 SELECT MONITOR	Class III
CA	84007	ULTRAVIEW DM3 MONITOR	Class III

ZOE MEDICAL, INCORPORATED

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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