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Master & Frank Enterprise Co., Ltd.

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Australia — 4 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

10listed device types

Class I 4Class II 6Class III 0

plus 11 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

134registered devices

Class I 133Class 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

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 Union742 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States11 registration records, 3 510(k), 0 PMA, 9 excluded

United Kingdom0 confirmed, 6 excluded

Brazil134 confirmed, 1 excluded

Manufacturer names merged into this page: MASTER & FRANK (CAMBODIA) CO., LTD. · MASTER & FRANK ENT. CO., LTD. · Master& Frank (PingHu) Co., Ltd. · Master& Frank (HuBei) Co., Ltd. · Master & Frank (Cambodia) Co., Ltd. · Master & Frank Enterprise Co., Ltd.

FDA 510(k) clearances by year

12001 · K012186

12002 · K020393

12018 · K172963

FDA listed device types

showing 8 of 10

Gown, Surgical 1Drape, Surgical, Exempt 1Respirator, Surgical 1Mask, Surgical 1Drape, Surgical, Antimicrobial 1Cover, Barrier, Protective 1Cap, Surgical 1Gown, Examination 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172963	Master-Frank N95 Particulate Respirator	2018-04-04
US	K020393	MASTER & FRANK SURGICAL DRAPES (STERILE)	2002-05-03
US	K012186	MASTER & FRANK SURGICAL GOWNS (STERILE)	2001-12-07
BR	80102511231	PACOTE CIRÚRGICO PARA EXTREMIDADES INFERIORES	Class I
BR	80102511232	PACOTE CIRÚRGICO PARA ORTOPEDIA I	Class I
BR	80102511227	PACOTE CIRÚRGICO PARA ORTOPEDIA0 V (Quadril)	Class I

Master & Frank Enterprise Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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