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GUANG ZHOU HE CHANG OPTICAL CO., LTD.

China · Guangzhou Guangdong

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

14listed device types

Class I 11Class II 1Class III 0unclassified 2

plus 27 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

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 States27 registration records, 0 510(k), 0 PMA, 5 excluded

Brazil3 confirmed, 1 excluded

Manufacturer names merged into this page: GUANG ZHOU MEDCLEAR MEDICAL DEVICE SERVICE CO.,LTD. · GUANG ZHOU MEDCLEAR MEDICAL DEVICE SERVICE CO., LTD. · GUANG ZHOU HE CHANG OPTICAL CO., LTD. · GUANG ZHOU WONDFO BIOTECH CO. LTDA

FDA listed device types

showing 8 of 14

Dressing, Wound, Drug 1Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua 1Closure, Wound, Adhesive 1Spectacle, Magnifying 1Mirror, Mouth 1Sunglasses (Non-Prescription Including Photosensitive) 1Explorer, Operative 1Catheters, Suction, Tracheobronchial 1

Market	Identifier	Name	Class / date
BR	10163770011	MATURITY TEST TESTE DE MENOPAUSA	Class II
BR	10163770009	FERTILITY DAY TESTE DE OVULAÇÃO	Class II
BR	80638720089	HCG RAPID TEST	Class II

GUANG ZHOU HE CHANG OPTICAL CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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