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SHANDONG RUYUE MEDICAL TECHNOLOGY CO.,LTD.

China · Binzhou Shandong

✓ Record-verifiedregistrations found in 3 markets

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

14listed device types

Class I 11Class II 3Class III 0

plus 14 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 4Class II 5

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

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 States14 registration records, 0 510(k), 0 PMA

Brazil9 confirmed, 0 excluded

Manufacturer names merged into this page: SHANDONG RUYUE MEDICAL TECHNOLOGY CO.,LTD. · SHANDONG RUYUE MEDICAL TECHNOLOGY CO , LTD

FDA listed device types

showing 8 of 14

Gauze / Sponge,Nonresorbable For External Use 1Patient Examination Glove 1Adaptor, Hygiene 1Disinfectant, Medical Devices 1Applicator, Absorbent Tipped, Non-Sterile 1Walker, Mechanical 1Spectrophotometric, Uroporphyrin 1Applicator, Absorbent Tipped, Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	82417650010	Touca Descartável com Elástico BetterCare	Class I
BR	82417650001	MÁSCARA CIRÚRGICA DESCARTÁVEL BC MED	Class I
BR	80808480069	Seringa Dosadora Oral BeCare	Class I

SHANDONG RUYUE MEDICAL TECHNOLOGY CO.,LTD.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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