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BENQ MATERIALS CORP.

Taiwan · Taoyuan · www.benqmaterials.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN TW-MF-000017429

This company has registrations in European Union, United States, United Kingdom, Brazil, Singapore, 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

14UDI-DI device records

Class I 14

USUnited StatesFDA openFDA

8listed device types

Class I 4Class II 3Class III 0unclassified 1

plus 11 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class III 1

BRBrazilANVISA

1registered devices

Class II 1

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

10device registrations

CLASS B 9CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

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.

European Union52 raw hits, 38 excluded, 14 confirmed

United States11 registration records, 4 510(k), 0 PMA, 3 excluded

United Kingdom1 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: BENQ MATERIALS CORP. YUNLIN FACTORY 3 · BENQ MATERIALS CORPORATION

Regulatory identity

EU manufacturer SRN: TW-MF-000017429
EU authorised representative: Obelis s.a.
UK responsible person: Obelis UK Ltd

FDA 510(k) clearances by year

22015 · K150963

12020 · K193185

12025 · K242056

FDA listed device types

Wrap, Sterilization 1Negative Pressure Wound Therapy Non-Powered Suction Apparatus 1Indicator, Physical/Chemical Sterilization Process 1Nursing Pad, Hydrogel 1Dressing, Wound, Hydrophilic 1Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1Elastomer, Silicone, For Scar Management 1Hemostatic Wound Dressing Without Thrombin Or Other Biologics 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	14719745505031	Anscare	Class I
EU	14719745056731	Anscare	Class I
EU	14719745592413	Anscare	Class I
EU	14719745592420	Anscare	Class I
UK	46922	AnsCare ChitoClot Artery Compression Device	Class III
US	K242056	miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus	2025-04-17
US	K193185	Anscare SIMO Negative Pressure Wound Therapy (NPWT) System	2020-05-04
US	K150963	AnsCare ChitoClot Pad	2015-11-05
BR	83037069002	Sistema de Terapia de Feridas por Pressão Negativa (NPWT) Anscare SIMO	Class II

BENQ MATERIALS CORP.

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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