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Luxamed GmbH & Co. KG

Germany · Blaubeuren · www.luxamed.de

✓ Record-verifiedregistrations found in 9 marketsEU SRN DE-MF-000006437

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 9 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

201UDI-DI device records

Class I 201

USUnited StatesFDA openFDA

2listed device types

Class I 2Class II 0Class III 0

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

18registered device records

Class I 18

BRBrazilANVISA

3registered devices

Class I 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

8registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 2Class 2a 2

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 Union201 raw hits, 0 excluded, 201 confirmed

United States2 registration records, 0 510(k), 0 PMA

United Kingdom18 confirmed, 0 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia8 confirmed, 0 excluded

Manufacturer names merged into this page: LUXAMED GMBH & CO. KG · LUXAMED GmbH & Co. KG

Regulatory identity

EU manufacturer SRN: DE-MF-000006437
UK responsible person: Advena Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04260381965466	LuxaScope Oculus 2.5V, black edition	Class I
EU	04260381965268	Reflexhammer nach Buck, Aluminium, grün KIDS	Class I
EU	04260381965251	LuxaScope Dermatoskop LED 2.5 V, white, Polarisation, WITH Scale	Class I
EU	04260381965244	LuxaScope Dermatoskop LED 2.5 V, black, Polarisation, WITH Scale	Class I
UK	18021	LuxaScope dermatoscope	Class I
UK	18021	LuxaScope Dermatoscope LED	Class I
UK	46786	Ophthalmoscope 2,5 V	Class I
BR	10243860065	Oftalmoscópios LuxaScope LED	Class I
BR	10243860066	Otoscópios LED LUXAMED	Class I
BR	10243860067	Dermatoscópios LED	Class I
SA	ME0000004686SFDAA00003	LuxaScope Auris	—
SA	ME0000004686SFDAA00006	Blades	—

Luxamed GmbH & Co. KG

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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