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TRACOE MEDICAL GMBH

Germany · Nieder-Olm

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

8listed device types

Class I 5Class II 3Class III 0

plus 12 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

47registered devices

Class II 47

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

4registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

8active device licences

Class II 8

18 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

6device registrations

CLASS B 3CLASS C 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

14active ARTG entries

Class I 5IIa 3IIb 4Class Im (measuring) 1Class Is (sterile) 1

HKHong KongMDACS

8valid listings

Class II 5Class III 3

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States12 registration records, 8 510(k), 0 PMA

Brazil47 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: TRACOE MEDICAL GMBH · TRACOE medical GmbH

FDA 510(k) clearances by year

11978 · K781729

11996 · K961449

22005 · K051587

22016 · K152778

12018 · K172720

12021 · K203362

FDA listed device types

Connector, Airway (Extension) 1Device, Fixation, Tracheal Tube 1Dilator, Tracheal 1Condenser, Heat And Moisture (Artificial Nose) 1Dressing, Wound, Occlusive 1Tube, Tracheostomy (W/Wo Connector) 1Tube Tracheostomy And Tube Cuff 1Cuff, Tracheal Tube, Inflatable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203362	TRACOE vario	2021-08-05
US	K172720	TRACOE silcosoft Tracheostomy Tube	2018-04-27
US	K152778	TRACOE Cuff Pressure Monitor	2016-12-21
BR	10273820052	CÂNULA DE TRAQUEOSTOMIA SEM BALÃO	Class II
BR	10273829014	TRACOE SMART CUFF - MEDIDOR DE PRESSÃO DE CUFF	Class II
BR	80171530074	Cânula de Traqueostomia Comfort - Ref.: 102/202	Class II
SA	ME0000004167SFDAA00001	Tracoe larynx	—
SA	ME0000004167SFDAA00002	Tracoe Neck Straps REF 903	—
CA	78611	TRACOE PURE TRACHEOSTOMY TUBE SET (WITH OBTURATORS)	Class II
CA	93315	CUFF PRESSURE MONITOR	Class II
CA	94766	TRACOE PHON ASSIST II SPEAKING VALVES REF 655-S AND REF 655-T WITH ATTACHABLE TRACOE HUMID ASSIST II REF 645	Class II