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ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD.

China · Zhengzhou Henan

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Australia, Israel — 5 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

21listed device types

Class I 17Class II 4Class III 0

plus 24 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

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

SASaudi ArabiaSFDA

6registered 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

5active ARTG entries

Class I 4IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States24 registration records, 1 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Saudi Arabia6 confirmed, 0 excluded

Manufacturer names merged into this page: ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD. · ZHENGZHOU MAGIQUE HUAER BIOTECH CO.,LTD. · ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO.,LTD. · Zhengzhou Huaer Electro-Optics Technology Co.,Ltd. · Zhengzhou Huaer Electro-Optics Technology Co., · ZHENGZHOU HUAER ELECTRO OPTICS TECHNOLOGY CO LTD

FDA 510(k) clearances by year

12020 · K201483

FDA listed device types

showing 8 of 21

Toothbrush, Powered 1Pusher, Band, Orthodontic 1Instruments, Dental Hand 1Eraser, Dental Stain 1Container, Specimen, Non-Sterile 1Tray, Impression, Preformed 1Retractor, All Types 1Orthosis, Moldable, Supportive, Skin Protective 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201483	Impression Material	2020-10-08
BR	10331439005	Oraltek White Clean	Class II
BR	10336320003	PLACAS RÍGIDAS PARA PLASTIFICAÇÃO A VÁCUO BORDENTE	Class I
BR	10336320004	PLACAS SOFT PARA PLASTIFICAÇÃO A VÁCUO BORDENTE	Class I
SA	ME0000006325SFDAA00011	Blan Quest ®	—
SA	ME0000007533SFDAA00001	TEETH WHITENING KIT	—

ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY 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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