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EUDAMED Device Search

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

Last updated

18.09.2026 19:42

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53 device results listed.

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MRSA/SA Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850117
Basic UDI-DI: B-06933289850117
Reference: WR42P0006
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

MRSA/SA Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850100
Basic UDI-DI: B-06933289850100
Reference: WR42P0005
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

MRSA/SA Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850094
Basic UDI-DI: B-06933289850094
Reference: WR42P0004
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Methicillin-resistant Staphylococcus aureus mecA Gene Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792734784
Basic UDI-DI: B-06955792734784
Reference: S3151E-48
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Methicillin-resistant Staphylococcus aureus mecA Gene Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792734777
Basic UDI-DI: B-06955792734777
Reference: S3151E-24
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

Staphylococcus Aureus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Staphylococcus Aureus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733756
Basic UDI-DI: B-06955792733756
Reference: S3143E-48
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Staphylococcus Aureus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Staphylococcus Aureus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733749
Basic UDI-DI: B-06955792733749
Reference: S3143E-24
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-039-25DN
Basic UDI-DI: B-EBX-039-25DN
Reference: EBX-039-25
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-039-10049
Basic UDI-DI: B-EBX-039-10049
Reference: EBX-039-100
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-039-50DM
Basic UDI-DI: B-EBX-039-50DM
Reference: EBX-039-50
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260221
Basic UDI-DI: 122000026NATERCK5
Reference: NATMSSA-6MC-IVD
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 08:27

Manufacturer products Authorised representative products Authorised representative actors View details

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260214
Basic UDI-DI: 122000026NATERCK5
Reference: NATMSSE-6MC-IVD
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260207
Basic UDI-DI: 122000026NATERCK5
Reference: NATMRSA-6MC-IVD
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 17.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Rabbit Coagulase Plasma

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Pro-Lab Diagnostics UK
Manufacturer SRN: GB-MF-000003833
UDI-DI: 50604724675466
Basic UDI-DI: B-50604724675466
Reference: PL.850-30
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Rabbit Coagulase Plasma

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Pro-Lab Diagnostics UK
Manufacturer SRN: GB-MF-000003833
UDI-DI: 50604724675398
Basic UDI-DI: B-50604724675398
Reference: PL.850-20
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Rabbit Coagulase Plasma

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Pro-Lab Diagnostics UK
Manufacturer SRN: GB-MF-000003833
UDI-DI: 50604724675220
Basic UDI-DI: B-50604724675220
Reference: PL.850-10
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Rabbit Coagulase Plasma

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Pro-Lab Diagnostics UK
Manufacturer SRN: GB-MF-000003833
UDI-DI: 50604724675152
Basic UDI-DI: B-50604724675152
Reference: PL.850-3
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Advena Limited
Last updated: 17.07.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® MRSA/SA Blood Culture

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940007140
Basic UDI-DI: B-07332940007140
Reference: GXMRSA/SABC-CE-10
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:56

Manufacturer products View details

Xpert® MRSA /SA SSTI

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940002473
Basic UDI-DI: B-07332940002473
Reference: GXMRSA/SA-SSTI-CE
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

Xpert® SA Nasal Complete

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940001889
Basic UDI-DI: B-07332940001889
Reference: GXSACOMP-CE-10
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details