SENTEC, INC.

Switzerland · Therwil

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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 0Class II 6Class III 0

plus 7 registration records and 7 510(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

1active device licences

Class II 1

2 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

16active ARTG entries

Class I 10IIa 2IIb 4

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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, 7 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: SENTEC AG · SENTEC, INC.

FDA 510(k) clearances by year

11986

12004

12007

12010

12015

12024

12025

FDA listed device types

Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia 1Oximeter, Ear 1Monitor, Carbon-Dioxide, Cutaneous 1Ventilatory Electrical Impedance Tomograph 1Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia 1Oximeter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243765	LuMon(TM) System	2025-08-07
US	K232516	Sentec Digital Monitoring System (SDMS) tCOM+	2024-05-17
US	K151329	SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet	2015-12-17
CA	85199	REUSABLE SPO2 SOFT SENSOR	Class II