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Intl. Optical Mfg. Co., Ltd.

Hong Kong · San Po Kong Kowloon

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 4Class II 0Class III 0

plus 22 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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.

United States22 registration records, 9 510(k), 0 PMA, 330 excluded

Brazil1 confirmed, 9 excluded

Saudi Arabia8 confirmed, 11 excluded

Canada0 confirmed, 11 excluded

Manufacturer names merged into this page: ENA OPTICAL MFG.CO.LTD · TR Optical Mfg Co., Ltd · UNIVERSE OPTICAL MFG CO.,LTD · CRISS OPTICAL MFG. CO., INC. · HANGZHOU KINGFISHER OPTICAL INSTRUMENT MFG CO.,LTD · Zhenjiang Select Optical MFG. Co., Ltd

FDA 510(k) clearances by year

11988

11991

11992

11993

21994

21995

11996

FDA listed device types

Lens, Spectacle (Prescription), For Reading Discomfort 1Spectacle, Magnifying 1Sunglasses (Non-Prescription Including Photosensitive) 1Frame, Spectacle 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K961286	STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES	1996-05-16
US	K951815	SUNGLASSES	1995-06-26
US	K946381	SUNGLASSES	1995-02-22
BR	80031729003	Refratômetro Manual Luxor RL-100	Class I
SA	ME0000000896SFDAA00001	Valtisto	—
SA	ME0000000064SFDAA00001	Valtisto	—

Intl. Optical Mfg. 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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