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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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603 device results listed.

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+ENTIPCOV61130D

GSD NovaPrime® TSP SARS-CoV-2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIPCOV61130D
Basic UDI-DI: B-+ENTIPCOV61130D
Reference: PCOV6113
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:16

Manufacturer products View details

+ENTICVGQ09700B

GSD NovaLisa SARS-CoV-2 (COVID-19) quantitative IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICVGQ09700B
Basic UDI-DI: B-+ENTICVGQ09700B
Reference: CVGQ0970
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICOVG094006

NovaLisa® SARS-CoV-2 (COVID-19) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICOVG094006
Basic UDI-DI: B-+ENTICOVG094006
Reference: COVG0940
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICOVA094000

NovaLisa® SARS-CoV-2 (COVID-19) IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICOVA094000
Basic UDI-DI: B-+ENTICOVA094000
Reference: COVA0940
EMDN: W0105041105
EMDN description: CORONAVIRUS IGA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTI301774470T

SARS-CoV-2 (COVID-19) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301774470T
Basic UDI-DI: B-+ENTI301774470T
Reference: 30177447
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

+ENTI301774460S

SARS-CoV-2 (COVID-19) IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI301774460S
Basic UDI-DI: B-+ENTI301774460S
Reference: 30177446
EMDN: W0105041105
EMDN description: CORONAVIRUS IGA
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:06

Manufacturer products View details

Aptima SARS-CoV-2 Assay

Aptima SARS-CoV-2 Assay

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045516991
Basic UDI-DI: 54200455DIAGAPTSARSCOV2CC
Reference: PRD-07881
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

ALINITY M SARS-COV-2

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999049192
Basic UDI-DI: 0884999AMN0006W8
Reference: 09N78-080
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

ABT-001

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 80845357043708
Basic UDI-DI: 08453570ABT-0014T
Reference: [ABT-001] QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

HE0066NS

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043570
Basic UDI-DI: 08453570HE0066NS32
Reference: [HE0066NS] Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Swab)
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0065N

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043563
Basic UDI-DI: 08453570HE0065NZF
Reference: [HE0065N] Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Pellet)
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

BD Respiratory Viral Panel for BD MAX™ System

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904453732
Basic UDI-DI: 038290QOYRIOCFPE
Reference: 445373
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-Nc005ZJ
Basic UDI-DI: B-Nc005ZJ
Reference: Nc005
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 14.07.2026 06:08

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 RT-qPCR DETECTION KIT

SARS-CoV-2 RT-qPCR DETECTION KIT

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: D-KSC2-AB692F
Basic UDI-DI: B-KSC2-AB692F
Reference: KSC2-AB69
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 14.07.2026 03:47

Manufacturer products View details

COVID-19 IgG Test kit (Colloidal Gold Method)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD47-02-1tJN
Basic UDI-DI: B-IVD47-02-1tJN
Reference: IVD47-02-1t
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG Rapid Test

COVID-19 IgG Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INCPG-R402CF
Basic UDI-DI: B-INCPG-R402CF
Reference: INCPG-R402
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 S-RBD IgG Antibody Rapid Test

SARS-CoV-2 S-RBD IgG Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICSG-R4028T
Basic UDI-DI: B-ICSG-R4028T
Reference: ICSG-R402
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralization Antibody Rapid Test

SARS-CoV-2 Neutralization Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICN-R402C2
Basic UDI-DI: B-ICN-R402C2
Reference: ICN-R402
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

CL AIA-PACK SARS-CoV-2-Ag ADJUSTER SET

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189216409
Basic UDI-DI: B-14560189216409
Reference: 0029274
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

CL AIA-PACK SARS-CoV-2-Ag TEST CUP

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189216393
Basic UDI-DI: B-14560189216393
Reference: 0029174
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details