Veriler yükleniyor…

Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

19.09.2026 17:45

Sync status

Successful

Device

3108040

Actor

47631

Certificate

3283

Filters

Show filters

Active filter:EMDN:W01050105

56 device results listed.

Page 2 / 3

STANDARD™ F Legionella Ag FIA

FLGN01G

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725623
Basic UDI-DI: 88001117IPCA01FA16W4
Reference: 10LEG20D
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® Legionella Urinary Ag

LIAISON® Legionella Urinary Ag

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104203
Basic UDI-DI: 805677131160043
Reference: 311600
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

D-697994388Nc041ZMDG

Legionella Nucleic Acid Detection Kit (Sputum/BALF)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Nc041ZMDG
Basic UDI-DI: B-697994388Nc041ZMDG
Reference: Nc041
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Fa041WF7P

Legionella Nucleic Acid Detection Kit (Fluorescence, Sputum/BALF)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Fa041WF7P
Basic UDI-DI: B-697994388Fa041WF7P
Reference: Fa041
EMDN: W0105010599
EMDN description: LEGIONELLA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella pneumophila IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE585110E
Basic UDI-DI: B-+ENTIRE585110E
Reference: RE58511
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

Legionella pneumophila IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE585010D
Basic UDI-DI: B-+ENTIRE585010D
Reference: RE58501
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTILEGM0650DS0Z

NovaLisa® Legionella pneumophila IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEGM0650DS0Z
Basic UDI-DI: B-+ENTILEGM0650DS0Z
Reference: LEGM0650DS
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEGM06500.

NovaLisa® Legionella pneumophila IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEGM06500.
Basic UDI-DI: B-+ENTILEGM06500.
Reference: LEGM0650
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEGG0650DS0T

NovaLisa® Legionella pneumophila IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEGG0650DS0T
Basic UDI-DI: B-+ENTILEGG0650DS0T
Reference: LEGG0650DS
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

+ENTILEGG06500V

NovaLisa® Legionella pneumophila IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTILEGG06500V
Basic UDI-DI: B-+ENTILEGG06500V
Reference: LEGG0650
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:15

Manufacturer products View details

Legionella Pneumophila Real Time PCR Kit

-

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB20110NW-50TMA
Basic UDI-DI: B-JB20110NW-50TMA
Reference: JB20110NW-50T
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella Pneumophila Real Time PCR Kit

-

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB20110NW-25TMA
Basic UDI-DI: B-JB20110NW-25TMA
Reference: JB20110NW-25T
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella Real Time PCR Kit

-

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB20107NW-50TQE
Basic UDI-DI: B-JB20107NW-50TQE
Reference: JB20107NW-50T
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella Real Time PCR Kit

-

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB20107NW-25TQE
Basic UDI-DI: B-JB20107NW-25TQE
Reference: JB20107NW-25T
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Legionella pneumophila qPCR Kit

RevoDx Legionella pneumophila qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212618
Basic UDI-DI: B-08684387212618
Reference: IP202327-100
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Legionella pneumophila qPCR Kit

RevoDx Legionella pneumophila qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212601
Basic UDI-DI: B-08684387212601
Reference: IP202327-25
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

GeneProof Legionella pneumophila PCR Kit

GeneProof Legionella pneumophila PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161951971
Basic UDI-DI: B-08594161951971
Reference: LP/ISEX/100
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

GeneProof Legionella pneumophila PCR Kit

GeneProof Legionella pneumophila PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161951957
Basic UDI-DI: B-08594161951957
Reference: LP/ISEX/025
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:48

Manufacturer products View details

The L.pn Rapid Test Device (urine)

A160301D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473047
Basic UDI-DI: B-06976753473047
Reference: A160301D
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella Pneumophila Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560570
Basic UDI-DI: B-06974858560570
Reference: P086H
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details