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GEM S.r.l.

Italy · Viareggio (LU) · www.gemitaly.it

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United Kingdom, Brazil, Hong Kong, Israel, Russia — 5 overseas markets. 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

0UDI-DI device records

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

13registered device records

Class IIa 11Class III 2

BRBrazilANVISA

4registered devices

Class I 1Class II 3

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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

9valid listings

Class II 8Class IV 1

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 2Class 2b 2Class 3 1

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 Union3,061 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States0 registration records, 0 510(k), 0 PMA, 5 excluded

United Kingdom13 confirmed, 18 excluded

Brazil4 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: GEM S.R.L.

Regulatory identity

UK responsible person: Selamedical UK Ltd

Business registration

LEI: 8156000785C4F6704428
Registration status: Active
Legal form: Società A Responsabilità Limitata (SRL)
Incorporated: 2019-11-15
Registered address: VIA PRATI, 16, ROVERETO, 38068
Registration authority: Business Register, no. 02569220227
Registry record updated: 2026-07-07

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
UK	58782	GLUBRAN 2 Seal Device 5/6	Class IIa
UK	58778	GLUBRAN 2 RIGID SPRAY DEVICE	Class IIa
UK	58778	GLUBRAN 2 RIGID SPRAY DEVICE	Class IIa
BR	80159010005	DISPOSITIVO GOTA A GOTA	Class II
BR	80159010031	Glutack	Class II
BR	80159019002	PONTEIRA APLICADORA	Class I

GEM S.r.l.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

Registration details (sample)

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