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Medis Medical(Tianjin)Co.,Ltd.

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Singapore, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

5listed device types

Class I 3Class II 2Class III 0

plus 5 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class I 2Class IIa 6

BRBrazilANVISA

16registered devices

Class I 1Class II 15

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

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIb 2Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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.

European Union16,188 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States5 registration records, 4 510(k), 0 PMA, 3 excluded

United Kingdom8 confirmed, 21 excluded

Brazil16 confirmed, 3 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: TIANJIN MEDIS MEDICAL DEVICE CO., LTD. · TIANJIN MEDIS MEDICAL DEVICE CO.,LTD.

Regulatory identity

UK responsible person: Etheria Medical Ltd

FDA 510(k) clearances by year

12006 · K060082

12017 · K160694

22019 · K190274

FDA listed device types

Tube, Tracheal (W/Wo Connector) 1Cuff, Tracheal Tube, Inflatable 1Airway, Oropharyngeal, Anesthesiology 1Stylet, Tracheal Tube 1Airway, Nasopharyngeal 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	46634	AccuCuffTM Cuff Pressure Indicator	Class IIa
UK	46967	Endotracheal Tube	Class IIa
UK	46967	Endotracheal Tube Nasal Preformed	Class IIa
US	K190274	Endotracheal Tube	2019-07-30
US	K182548	Accucuff Cuff Pressure Indicator	2019-01-25
US	K160694	Disposable Endotracheal tube, sterile, AccuCuff	2017-04-07
BR	10150479153	Sonda Máscara Laringea Descartável Flowguard com Accucuff Medis	Class II
BR	10150479154	Sonda Máscara Laringea Descartável em Silicone Medis com Accucuff	Class II
BR	10150479155	Sonda Máscara Laringea Descartável em PVC Medis com Accucuff	Class II
CA	81531	LARYNGEAL MASK - SILICONE	Class II

Medis Medical(Tianjin)Co.,Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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