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GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.

China · Guilin

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel — 7 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

7listed device types

Class I 4Class II 3Class III 0

plus 7 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 3Class II 5

9 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

5 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 3IIa 8

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States7 registration records, 3 510(k), 0 PMA, 2 excluded

Brazil8 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: GUILIN REFINE MEDICAL INSTRUMENT CO., LTD. · GUILIN REFINE MEDICAL INSTRUMENT CO., LTD · Guilin Refine Medical Instrument Co., LTD

FDA 510(k) clearances by year

22023 · K230641

12026 · K254018

FDA listed device types

Pick, Massaging 1Plugger, Root Canal, Endodontic 1Unit, Suction Operatory 1Agent, Polishing, Abrasive, Oral Cavity 1Scaler, Ultrasonic 1Activator, Ultraviolet, For Polymerization 1Unit, X-Ray, Extraoral With Timer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254018	Portable Dental X-ray Device (GT-1)	2026-02-19
US	K230641	Ultrasonic Scaler Tips	2023-11-21
US	K223414	Curing Light, Model: MaxCure 9	2023-11-15
BR	80676929025	Ultrassom Odontológico Advance	Class II
BR	80676920068	Fotopolimerizador Blue Star	Class I
BR	81034259006	Lâmpada de Fotopolimerazação	Class II
SA	ME0000017327SFDAA00001	Face Shield	—

GUILIN REFINE MEDICAL INSTRUMENT 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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