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Foremount Enterprise Co., Ltd.

✓ Record-verifiedregistrations found in 7 marketsEU SRN TW-MF-000006734

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Australia, Israel — 7 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

56UDI-DI device records

Class I 56

USUnited StatesFDA openFDA

30listed device types

Class I 23Class II 7Class III 0

plus 30 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class I 3Class IIa 4

BRBrazilANVISA

9registered devices

Class I 3Class II 6

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

10active device licences

Class II 10

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 3IIa 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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.

European Union56 raw hits, 0 excluded, 56 confirmed

United States30 registration records, 1 510(k), 0 PMA, 1 excluded

United Kingdom7 confirmed, 0 excluded

Brazil9 confirmed, 0 excluded

Canada10 confirmed, 0 excluded

Manufacturer names merged into this page: FOREMOUNT ENTERPRISE CO., LTD. · Foremount Enterprise CO., Ltd

Regulatory identity

EU manufacturer SRN: TW-MF-000006734
EU authorised representative: Advena Limited
UK responsible person: Advena Ltd

FDA 510(k) clearances by year

12018 · K170663

FDA listed device types

showing 8 of 30

Mouthpiece, Breathing 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Mask, Oxygen, Non-Rebreathing 1Mask, Gas, Anesthetic 1Accessory Equipment, Cardiopulmonary Bypass 1Stylet, Tracheal Tube 1Laryngoscope, Rigid 1Gag, Mouth 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719871891766	Harness (Medium/Small) for CPAP Face Mask	Class I
EU	04719871891759	Harness (Large/Medium) for CPAP Face Mask	Class I
EU	04719871894293	—	Class I
EU	04719871891742	FOUR POINT SILICONE HARNESS - CHILD	Class I
UK	46232	Disposable Aircushion Mask	Class IIa
UK	60882	Harness	Class I
UK	61326	Pocket Size Resuscitator	Class IIa
US	K170663	Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer	2018-05-11
BR	10273829015	Máscara de Silicone com Coxim Inflável Newmed	Class II
BR	81194869014	MedMacro	Class II
BR	10273820069	Bolsa Pressurizadora	Class I
CA	74925	EMERGENCY MASK	Class II
CA	75066	MANUAL RESUSCITATOR	Class II
CA	75580	AIRWAY	Class II

Foremount Enterprise 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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