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Guangzhou Heygears IMC., Inc.

China · Guangzhou Guangdong

✓ Record-verifiedregistrations found in 3 markets

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

10listed device types

Class I 6Class II 3Class III 0unclassified 1

plus 18 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class 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

4active ARTG entries

Class I 4

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 States18 registration records, 4 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: GUANGZHOU HEYGEARS IMC.INC

FDA 510(k) clearances by year

12022 · K213643

12025 · K253324

22026 · K261626

FDA listed device types

showing 8 of 10

Plate, Base, Shellac 1Wax, Dental, Intraoral 1Positioner, Tooth, Preformed 1Material, External Aesthetic Restoration, No Adhesive 1Accessories, Implant, Dental, Endosseous 1Material, Impression Tray, Resin 1Mouthguard, Prescription 1Crown And Bridge, Temporary, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261626	UltraPrint Flexible Denture UV	2026-08-13
US	K253798	UltraPrint-Dental Hard Splint UV	2026-03-02
US	K253324	UltraPrint-Dental Denture UV	2025-11-20
BR	80117580987	UltraPrint Tray UV	Class I
BR	80117589052	UltraPrint Surgical Guide UV	Class II
BR	80117589054	UltraPrint Temp C&B UV	Class II

Guangzhou Heygears IMC., Inc.

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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