Infomed SA

Switzerland · Meinier · www.infomed.swiss

✓ Record-verifiedregistrations found in 8 marketsEU SRN CH-MF-000021686

This company has registrations in European Union, United States, United Kingdom, Taiwan, Australia, Hong Kong, Israel, Russia — 8 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

87UDI-DI device records

Class I 11Class IIa 59Class IIb 17

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class IIa 2Class IIb 1

BRBrazilANVISA

0registered devices

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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIb 3

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 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 Union96 raw hits, 9 excluded, 87 confirmed

United States2 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom3 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: INFOMED SA

Regulatory identity

EU manufacturer SRN: CH-MF-000021686
EU authorised representative: INFOMED SAS
UK responsible person: LINC Medical Systems Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	07640137442743	IN300	Class IIb
EU	07640137442408	Tuline 065	Class I
EU	07640137442880	IDLINE 020	Class I
EU	07640137440824	TULINE 306	Class IIa
UK	58091	0.30 sqm Granopen plasmafilter	Class IIa
UK	16405	HF4+A2:D1840-05 Infomed Purification Machine	Class IIb
UK	47334	1.40 sqm Pecopen hemofilter	Class IIa

Infomed SA

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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