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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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01.08.2026 18:27

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51 device results listed.

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Emit Amikacin Assay

IVDR_67_GLA_DUB-C_C_REAG_KIT_Amikacin Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001543
Basic UDI-DI: 0405686901046V2
Reference: 10445383
EMDN: W0102080301
EMDN description: AMIKACIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Gentamicin Plus Assay

IVDR_67_GLA_DUB-C_B_REAG_Gentamicin Plus Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001086
Basic UDI-DI: 0405686901118V2
Reference: 10445333
EMDN: W0102080307
EMDN description: GENTAMICIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Vancomycin (Vanc)

IVDR_67_TTN_DUB-C_C_REAG_VANC_2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596020
Basic UDI-DI: 0405686901903VV
Reference: 11097511
EMDN: W0102080319
EMDN description: VANCOMYCIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Tobramycin (Tob)

IVDR_67_TTN_DUB-C_C_REAG_TOB

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595962
Basic UDI-DI: 0405686901778WJ
Reference: 11097517
EMDN: W0102080317
EMDN description: TOBRAMYCIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® 2000 Gentamicin Plus Assay

IVDR_67_GLA_DUB-C_B_REAG_Gentamicin Plus Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023316
Basic UDI-DI: 0405686901118V2
Reference: 10445335
EMDN: W0102080307
EMDN description: GENTAMICIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Tobramycin Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_TOBR

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005381
Basic UDI-DI: 0405686901202UQ
Reference: 10444928
EMDN: W0102080317
EMDN description: TOBRAMYCIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Vancomycin Assay

IVDR_67_GLA_DUB-C_C_REAG_Vancomycin Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001109
Basic UDI-DI: 0405686901221UU
Reference: 10445336
EMDN: W0102080319
EMDN description: VANCOMYCIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Tobramycin Assay

IVDR_67_GLA_DUB-C_B_REAG_Tobramycin Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001062
Basic UDI-DI: 0405686901203US
Reference: 10445330
EMDN: W0102080317
EMDN description: TOBRAMYCIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

MS9700

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS9700CW
Basic UDI-DI: B-MS9700CW
Reference: MS9700
EMDN: W0102080399
EMDN description: ANTIBIOTICS TDM - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:16

Manufacturer products View details

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-MFG030062QU
Basic UDI-DI: B-MFG030062QU
Reference: MFG030062
EMDN: W0102080399
EMDN description: ANTIBIOTICS TDM - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 14.07.2026 05:06

Manufacturer products View details

Vancomycin Reagent (VANC 2 x 100)

Vancomycin Reagent (VANC 2 x 100)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474824RA
Basic UDI-DI: B-474824RA
Reference: 474824
EMDN: W0102080319
EMDN description: VANCOMYCIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

Gentamicin Reagent (GEN 2 x 100)

Gentamicin Reagent (GEN 2 x 100)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469137R8
Basic UDI-DI: B-469137R8
Reference: 469137
EMDN: W0102080307
EMDN description: GENTAMICIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Tobramycin Reagent (TOB 2 x 100)

Tobramycin Reagent (TOB 2 x 100)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-467983S9
Basic UDI-DI: B-467983S9
Reference: 467983
EMDN: W0102080317
EMDN description: TOBRAMYCIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Antibiotics Reagent Set

4300 P ABX

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testing

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4300PABXJP
Basic UDI-DI: B-4300PABXJP
Reference: 4300 P ABX
EMDN: W0102080319
EMDN description: VANCOMYCIN
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:44

Manufacturer products View details

RapidFor™ Vancomycin Rapid Test Kit (FIA)

VMPO32

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250438
Basic UDI-DI: B-08683548250438
Reference: VMPO32
EMDN: W0102080319
EMDN description: VANCOMYCIN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:10

Manufacturer products View details

09026924190

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 07613336190807
Basic UDI-DI: B-07613336190807
Reference: 09026924190
EMDN: W0102080307
EMDN description: GENTAMICIN
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 07.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

09086137190

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 07613336190753
Basic UDI-DI: B-07613336190753
Reference: 09086137190
EMDN: W0102080307
EMDN description: GENTAMICIN
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 07.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

Human Monkeypox Virus (MPV) IgGIgM Antibody Rapid Test Device（Colloidal Gold)

A060501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753476086
Basic UDI-DI: B-06976753476086
Reference: A060501D
EMDN: W0102080399
EMDN description: ANTIBIOTICS TDM - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold)

A051601D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753476055
Basic UDI-DI: B-06976753476055
Reference: A051601D
EMDN: W0102080399
EMDN description: ANTIBIOTICS TDM - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-Cov-2＆ FLU A&B & RSV & Adv Combo Rapid Test Cassett(swab)

A141301D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753472958
Basic UDI-DI: B-06976753472958
Reference: A141301D
EMDN: W0102080399
EMDN description: ANTIBIOTICS TDM - OTHER
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