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EUDAMED Device Search

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

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PATHODX EXTRACTION REAGENT 1

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501314
Basic UDI-DI: 50560805PathoDXReagGN
Reference: R62052
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX EXTRACTION REAGENT 2

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501321
Basic UDI-DI: 50560805PathoDXReagGN
Reference: R62055
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX EXTRACTION REAGENT 2

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501338
Basic UDI-DI: 50560805PathoDXReagGN
Reference: R62057
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX EXTRACTION REAGENT 3

-

IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501345
Basic UDI-DI: 50560805PathoDXReagGN
Reference: R62060
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX STREP GROUPING UNIVERSAL KIT

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501369
Basic UDI-DI: 50560805PathDXStrepC7
Reference: R62150
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501383
Basic UDI-DI: 50560805StreptexU9
Reference: R30164701
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX B

-

IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501413
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30950701
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX C

-

IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501420
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30950801
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX D

-

IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501437
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30950901
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX F

-

IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501444
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30951101
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX G

-

IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501451
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30951201
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

Shigella Rapid Test Cassette

Shigella Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISH-625UX
Basic UDI-DI: B-ISH-625UX
Reference: ISH-625
EMDN: W0105011714
EMDN description: SHIGELLA
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 20.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter pylori(HP) IgG Test Kit(CLIA)

Helicobacter pylori(HP) IgG Test Kit(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CI-HPG9K
Basic UDI-DI: B-CI-HPG9K
Reference: CI-HPG
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 20.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® Mycoplasma pneumoniae IgM

LIAISON® Mycoplasma pneumoniae IgM

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

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771101202
Basic UDI-DI: 80567713170304Q
Reference: 317030
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 19.07.2026 12:37

Manufacturer products View details

LIAISON® Mycoplasma pneumoniae IgG

LIAISON® Mycoplasma pneumoniae IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771101189
Basic UDI-DI: B-08056771101189
Reference: 317020
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Italy
Authorised representative: -
Last updated: 19.07.2026 12:37

Manufacturer products View details

STANDARD™ M10 vanA/vanB

M10-VAN-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723100
Basic UDI-DI: 88001117IPCA01MA20XC
Reference: 11VAN10A
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 18.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors View details

Bordetella Pertussis Antigen Rapid Test Kit (Colloidal Gold)

GCBP-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCBP-502aOGKF
Basic UDI-DI: B-GCBP-502aOGKF
Reference: GCBP-502a
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Bordetella Real Time PCR Detection Kit

VIASURE Bordetella Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440202127
Basic UDI-DI: 84354402_MDXRESPB_BDT4F
Reference: VS-BDT106L
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 22:54

Manufacturer products View details

VIASURE Bordetella Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440222040
Basic UDI-DI: 84354402_MDXRESPB_BDT4F
Reference: VS-BDT101L
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:38

Manufacturer products View details

VIASURE Bordetella Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440222057
Basic UDI-DI: 84354402_MDXRESPB_BDT4F
Reference: VS-BDT101H
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:38

Manufacturer products View details