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SHANDONG LEE MED TECHNOLOGY CO., LTD.

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000025405

This company has registrations in European Union, United Kingdom, Brazil, Australia — 4 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

79UDI-DI device records

Class I 26Class IIa 53

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class I 1Class IIa 1

BRBrazilANVISA

2registered devices

Class I 2

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

3active ARTG entries

IIa 2Class Is (sterile) 1

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.

European Union220 raw hits, 141 excluded, 79 confirmed

United States0 registration records, 0 510(k), 0 PMA, 23 excluded

United Kingdom2 confirmed, 14 excluded

Brazil2 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SHANDONG LEE MED MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000025405
EU authorised representative: MedPath GmbH
UK responsible person: SPIRIT MEDICAL LTD

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06973507548723	Transfer Sets	Class I
EU	06973507548716	Transfer Sets	Class I
EU	06973507540864	Extension Sets	Class IIa
EU	06973507540857	Extension Sets	Class IIa
UK	38569	Gravity Administration Blood Set	Class IIa
UK	35177	Type IIR Medical Face Mask	Class I
BR	80305560109	MPSET Ext Cateter	Class I
BR	80305560110	MPSET Ext Perfusão	Class I

SHANDONG LEE MED TECHNOLOGY CO., LTD.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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