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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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124 device results listed.

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Cytomegalovirus (CMV) IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE570610D
Basic UDI-DI: B-+ENTIRE570610D
Reference: RE57061
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

Manufacturer products View details

+ENTIEIA-59640C

Avidity Cytomegalovirus (CMV) IgG ELISA

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-59640C
Basic UDI-DI: B-+ENTIEIA-59640C
Reference: EIA-5964
EMDN: W0105040206
EMDN description: CMV IGG - AVIDITY
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIEIA-382304

Cytomegalovirus (CMV) IgM ELISA

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-382304
Basic UDI-DI: B-+ENTIEIA-382304
Reference: EIA-3823
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTIEIA-380807

Cytomegalovirus (CMV) IgG ELISA

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-380807
Basic UDI-DI: B-+ENTIEIA-380807
Reference: EIA-3808
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

+ENTICMVM0110DS0/

NovaLisa® Cytomegalovirus (CMV) IgM

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICMVM0110DS0/
Basic UDI-DI: B-+ENTICMVM0110DS0/
Reference: CMVM0110DS
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICMVM01100%

NovaLisa® Cytomegalovirus (CMV) IgM

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICMVM01100%
Basic UDI-DI: B-+ENTICMVM01100%
Reference: CMVM0110
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICMVG0110DS0Y

NovaLisa® Cytomegalovirus (CMV) IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICMVG0110DS0Y
Basic UDI-DI: B-+ENTICMVG0110DS0Y
Reference: CMVG0110DS
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTICMVG01100-

NovaLisa® Cytomegalovirus (CMV) IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTICMVG01100-
Basic UDI-DI: B-+ENTICMVG01100-
Reference: CMVG0110
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:10

Manufacturer products View details

+ENTIACMV71100.

NovaLisa® Avidity Cytomegalovirus (CMV) IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIACMV71100.
Basic UDI-DI: B-+ENTIACMV71100.
Reference: ACMV7110
EMDN: W0105040206
EMDN description: CMV IGG - AVIDITY
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:08

Manufacturer products View details

GeneProof Cytomegalovirus (CMV) MC PCR Kit

GeneProof Cytomegalovirus (CMV) MC PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696303891
Basic UDI-DI: 859569630055QS
Reference: CMV/MC/041
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:33

Manufacturer products View details

Aptima CMV Quant Assay

Aptima CMV Quant Assay

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514553
Basic UDI-DI: 54200455DIAGAPTCMVAP
Reference: PRD-05074
EMDN: W0105040205
EMDN description: CMV - 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 CMV WB

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999050990
Basic UDI-DI: 0884999AMN0024WA
Reference: 09N46-072
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details

ALINITY M CMV

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999049567
Basic UDI-DI: 0884999AMN0946XZ
Reference: 09N46-070
EMDN: W0105040205
EMDN description: CMV - 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

IMMULITE 2000 CMV IgM

IVDR_67_LLB_DUB-C_C_KIT_CMV IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961163
Basic UDI-DI: 0405686901445VL
Reference: 10381320
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

50 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1891646
Basic UDI-DI: B-R1891646
Reference: R18916
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

30 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1891544
Basic UDI-DI: B-R1891544
Reference: R18915
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

200 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1891442
Basic UDI-DI: B-R1891442
Reference: R18914
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

100 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R189133Y
Basic UDI-DI: B-R189133Y
Reference: R18913
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

50 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R189123W
Basic UDI-DI: B-R189123W
Reference: R18912
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

30 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R189113U
Basic UDI-DI: B-R189113U
Reference: R18911
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details