LSM-Med S.r.l.

San Marino · Serravalle · www.lsm-med.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN SM-MF-000033593

This company has registrations in European Union, United States, United Kingdom, Brazil — 4 overseas markets. EU UDI-DI records ≥200, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

≥200UDI-DI device records

Class I 187Class IIa 13

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

17listed device types

Class I 0Class II 17Class III 0

plus 22 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

28registered device records

Class I 16Class IIa 3Class IIb 6Class III 3

BRBrazilANVISA

8registered devices

Class I 7Class II 1

11 including historic records

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

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 Union209 raw hits, 0 excluded, 200 confirmed. Large result set — only the first 300 verified

United States22 registration records, 0 510(k), 0 PMA

United Kingdom28 confirmed, 0 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: LSM-MED S.r.l. · LSM-MED SRL

Regulatory identity

EU manufacturer SRN: SM-MF-000033593
EU authorised representative: Overmed srl
UK responsible person: Regulatus Ltd

FDA listed device types

showing 8 of 17

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08033051098162	Depth gauge for proximal holes	Class I
EU	08033051095697	Measuring device	Class I
EU	08033051095468	Measuring device for cephalic screw	Class I
EU	08033051019136	Measuring device	Class I
UK	15275	Awl	Class I
UK	17507	Ø 7 mm tap - AO coupling	Class I
UK	11332	Cannulated drill bit Ø 2 mm	Class IIa
BR	80070180085	Kit Instrumental Haste SuperNail GT Longa - HSJ 0300	Class I
BR	80070180086	Kit Instrumental Fios Guias Haste SuperNail GT	Class I
BR	80070180089	Kit Instrumental Haste SuperNail GT Padrão - HSJ 0200	Class I

LSM-Med S.r.l.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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