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01.08.2026 01:12

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19 device results listed.

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LEGIONELLA LATEX TEST

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013197
Basic UDI-DI: 5032384LegionAgglutKitB5
Reference: DR0800M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

LEGIONELLA PNEUMO GROUP 1

LEGIONELLA LATEX TEST

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013203
Basic UDI-DI: 5032384LegionAgglutLtxCK
Reference: DR0801M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

LEGIONELLA PNEUMO GROUPS 2-14

IVD Class BNot specifiedOn the market

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013210
Basic UDI-DI: 5032384LegionAgglutLtxCK
Reference: DR0802M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

LEGIONELLA SPECIES TEST KIT

IVD Class BNot specifiedOn the market

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013227
Basic UDI-DI: 5032384LegionAgglutLtxCK
Reference: DR0803M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

DRYSPOT LEGIONELLA PNEUMOPHILA 1

DRYSPOT LEGIONELLA

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384060535
Basic UDI-DI: 5032384DSLegionellaXZ
Reference: DR0200M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

DRYSPOT LEGIONELLA PNEUMOPHILA 2-14

IVD Class BNot specifiedOn the market

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384060542
Basic UDI-DI: 5032384DSLegionellaXZ
Reference: DR0210M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

DRYSPOT LEGIONELLA SPECIES

IVD Class BNot specifiedOn the market

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384061365
Basic UDI-DI: 5032384DSLegionellaXZ
Reference: DR0220M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella pneumophila Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-LEG-102NV
Basic UDI-DI: B-FI-LEG-102NV
Reference: FI-LEG-102
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

The L.pn Rapid Test Device

K780316D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053274
Basic UDI-DI: B-06971792053274
Reference: K780316D
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

04049095030390

RIDASCREEN® Legionella

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030390
Basic UDI-DI: 4049095C800100000LH
Reference: C8001
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:50

Manufacturer products View details

VELLAP Legionella

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VELLAP Diagnostics GmbH
Manufacturer SRN: DE-MF-000035636
UDI-DI: 04260743470539
Basic UDI-DI: B-04260743470539
Reference: 2.13.6.11
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:14

Manufacturer products View details

04049095030819

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030819
Basic UDI-DI: 4049095C800100000LH
Reference: C8001C00-VK
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 22:40

Manufacturer products View details

04049095030826

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030826
Basic UDI-DI: 4049095C800100000LH
Reference: C8001C01-VK
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 22:40

Manufacturer products View details

04049095030833

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030833
Basic UDI-DI: 4049095C800100000LH
Reference: C8001K01-VK
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 22:40

Manufacturer products View details

04049095030840

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095030840
Basic UDI-DI: 4049095C800100000LH
Reference: C8001K02-VK
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 22:40

Manufacturer products View details

04049095260551

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095260551
Basic UDI-DI: 4049095C800100000LH
Reference: CRP8004
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 22:40

Manufacturer products View details