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EUDAMED Device Search

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

TREN

Last updated

23.09.2026 19:29

Sync status

Successful

Device

3578850

Actor

47827

Certificate

3401

Active filter:Manufacturer SRN:DE-MF-000025020

420 device results listed.

Page 10 / 21

CSVXML
+ENTIEIA-384407

Measles Virus IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEIA-384407
Basic UDI-DI
B-+ENTIEIA-384407
Reference
EIA-3844
EMDN
W0105040702
EMDN description
MEASLES VIRUS IGG
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEIA-384306

Leishmania infantum IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEIA-384306
Basic UDI-DI
B-+ENTIEIA-384306
Reference
EIA-3843
EMDN
W0105050205
EMDN description
LEISHMANIA
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEIA-384003

Herpes Simplex Virus 1+2 IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEIA-384003
Basic UDI-DI
B-+ENTIEIA-384003
Reference
EIA-3840
EMDN
W0105040304
EMDN description
HSV 1+2 IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEIA-38390B

Herpes Simplex Virus 1+2 IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEIA-38390B
Basic UDI-DI
B-+ENTIEIA-38390B
Reference
EIA-3839
EMDN
W0105040303
EMDN description
HSV 1+2 IGG
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView 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 productsView details
+ENTIEIA-381101

Chlamydia trachomatis 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-381101
Basic UDI-DI
B-+ENTIEIA-381101
Reference
EIA-3811
EMDN
W0105010111
EMDN description
CHLAMYDIA TRACHOMATIS ANTIBODY IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEIA-381000

Chlamydia trachomatis 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-381000
Basic UDI-DI
B-+ENTIEIA-381000
Reference
EIA-3810
EMDN
W0105010110
EMDN description
CHLAMYDIA TRACHOMATIS ANTIBODY IGG
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEIA-380908

Chlamydia trachomatis IgA 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-380908
Basic UDI-DI
B-+ENTIEIA-380908
Reference
EIA-3809
EMDN
W0105010109
EMDN description
CHLAMYDIA TRACHOMATIS ANTIBODY IGA
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView 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 productsView details
+ENTIECHG0130DS0E

NovaLisa® Echinococcus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIECHG0130DS0E
Basic UDI-DI
B-+ENTIECHG0130DS0E
Reference
ECHG0130DS
EMDN
W0105050204
EMDN description
ECHINOCOCCUS
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIECHG01300G

NovaLisa® Echinococcus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIECHG01300G
Basic UDI-DI
B-+ENTIECHG01300G
Reference
ECHG0130
EMDN
W0105050204
EMDN description
ECHINOCOCCUS
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEBVM0150DS0Z

NovaLisa® Epstein-Barr Virus (VCA) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEBVM0150DS0Z
Basic UDI-DI
B-+ENTIEBVM0150DS0Z
Reference
EBVM0150DS
EMDN
W010504040104
EMDN description
EBV VCA IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEBVM01500.

NovaLisa® Epstein-Barr Virus (VCA) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEBVM01500.
Basic UDI-DI
B-+ENTIEBVM01500.
Reference
EBVM0150
EMDN
W010504040104
EMDN description
EBV VCA IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEBVG0580DS0-

NovaLisa® Epstein-Barr Virus (EBNA) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEBVG0580DS0-
Basic UDI-DI
B-+ENTIEBVG0580DS0-
Reference
EBVG0580DS
EMDN
W010504040106
EMDN description
EBV EBNA IGG
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEBVG05800_

NovaLisa® Epstein-Barr Virus (EBNA) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEBVG05800_
Basic UDI-DI
B-+ENTIEBVG05800_
Reference
EBVG0580
EMDN
W010504040106
EMDN description
EBV EBNA IGG
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEBVG00800X

NovaLisa® Epstein-Barr Virus (EA-D) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEBVG00800X
Basic UDI-DI
B-+ENTIEBVG00800X
Reference
EBVG0080
EMDN
W010504040108
EMDN description
EBV EA IGG
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEBVA01500P

NovaLisa® Epstein-Barr Virus (VCA) IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEBVA01500P
Basic UDI-DI
B-+ENTIEBVA01500P
Reference
EBVA0150
EMDN
W010504040199
EMDN description
EBV ANTIBODIES - OTHER
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEBVG0150DS0T

NovaLisa® Epstein-Barr Virus (VCA) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEBVG0150DS0T
Basic UDI-DI
B-+ENTIEBVG0150DS0T
Reference
EBVG0150DS
EMDN
W010504040105
EMDN description
EBV VCA IGG
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIEBVG01500V

NovaLisa® Epstein-Barr Virus (VCA) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEBVG01500V
Basic UDI-DI
B-+ENTIEBVG01500V
Reference
EBVG0150
EMDN
W010504040105
EMDN description
EBV VCA IGG
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details
+ENTIDVM0640DS0R

NovaLisa® Dengue Virus IgM µ-capture

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIDVM0640DS0R
Basic UDI-DI
B-+ENTIDVM0640DS0R
Reference
DVM0640DS
EMDN
W0105040611
EMDN description
DENGUE VIRUS
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:12
Manufacturer productsView details