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SML MED-TECH SOLUTIONS LIMITED

✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000031313Unified social credit code 91440404MABMR5761H

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia — 7 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

115UDI-DI device records

Class I 42Class IIa 73

USUnited StatesFDA openFDA

6listed device types

Class I 4Class II 2Class III 0

plus 6 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class I 4

BRBrazilANVISA

6registered devices

Class I 6

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

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 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 Union121 raw hits, 6 excluded, 115 confirmed

United States6 registration records, 1 510(k), 0 PMA, 2 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom4 confirmed, 0 excluded

Brazil6 confirmed, 0 excluded

Manufacturer names merged into this page: SML MED-TECH SOLUTIONS LIMITED

Regulatory identity

EU manufacturer SRN: CN-MF-000031313
EU authorised representative: Share info GmbH
UK responsible person: Omnimed Limited
Unified social credit code: 91440404MABMR5761H
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

12023 · K220884

FDA listed device types

Endoscope Channel Accessory 1Bottle, Collection And Trap, Breathing System (Uncalibrated) 1Adaptor, Bulbs, Miscellaneous, For Endoscope 1Endoscopic Bite Block 1Accessories, Cleaning Brushes, For Endoscope 1Basin For Endoscope Reprocessing 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04897129991687	Loremed®	Class I
EU	04897129991670	Loremed®	Class I
EU	04897129991663	Loremed®	Class I
EU	04897129991540	Loremed®	Class IIa
UK	66650	Air Water Channel Cleaning Adapter (Non-Sterile)	Class I
UK	34143	Bite Block Round Shape, with Strap and Dental Rim (Non-Sterile)	Class I
UK	64018	Disposable Tip Protector	Class I
US	K220884	Disposable Endoscope Valve Sets	2023-01-17
BR	82214240014	GuardPro Valve	Class I
BR	82214240015	Orion Trap	Class I
BR	82214240016	GuardPro Liner	Class I

SML MED-TECH SOLUTIONS LIMITED

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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