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GUILIN YIKESHI Medical Device CO LTD

China · Guilin Guangxi

✓ Record-verifiedregistrations found in 3 markets

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

28listed device types

Class I 26Class II 2Class III 0

plus 28 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

1 including historic records

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 States28 registration records, 0 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: GUILIN YIKESHI Medical Device CO LTD · GUILIN YIKESHI MEDICAL INSTRUMENT CO, LTD · GUILIN YIKESHI MEDICAL INSTRUMENT CO.,LTD. · GUILIN YIKESHI MACHINE CO., LTD

Same-named companies — This database also contains companies with near-identical names: GUILIN YIKESHI MACHINE CO., LTD, GUILIN YIKESHI MEDICAL INSTRUMENT CO.,LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA listed device types

showing 8 of 28

Chair, Surgical, Non-Electrical 1Curette, Periodontic 1Preparer, Root Canal Endodontic 1Accessories, Implant, Dental, Endosseous 1Unit, Oral Irrigation 1Elevator, Surgical, Dental 1Point, Paper, Endodontic 1Chisel, Bone, Surgical 1

Market	Identifier	Name	Class / date
BR	82176160034	ÓCULOS LUPA CIRÚRGICA XPEDENT/SIMS OPTICS	Class I
BR	81040530013	PONTA ULTRASSÔNICA XPEDENT*	Class II

GUILIN YIKESHI Medical Device CO LTD

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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