Public EUDAMED Search

EUDAMED Device Search

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

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DyonMono

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251200630
Basic UDI-DI: B-05200251200630
Reference: DNWA105
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:47

Manufacturer products View details

DyonHpsA

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251200500
Basic UDI-DI: B-05200251200500
Reference: DNGL103
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:47

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Positive Control Flu

IVD generalIVDDOn the marketAnimal tissuesReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815071110
Basic UDI-DI: B-04987815071110
Reference: ACPC7111
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY/NAT - RT & POC
First on market country: Latvia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:45

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia hMPV Test Plate 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815016715
Basic UDI-DI: B-04987815016715
Reference: CAHM1671
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:45

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia hMPV 20T/Box

IVD generalNot specifiedOn the marketSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815016708
Basic UDI-DI: B-04987815016708
Reference: CAHM1670
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Mycoplasma 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815015718
Basic UDI-DI: B-04987815015718
Reference: CAMP1571
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Strep A 20T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815011703
Basic UDI-DI: B-04987815011703
Reference: CAST1170
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia RSV Neo Test Plate 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815009717
Basic UDI-DI: B-04987815009717
Reference: CARS0971
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia RSV Neo 20T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815009700
Basic UDI-DI: B-04987815009700
Reference: CARS0970
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Flu Neo 20T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815005702
Basic UDI-DI: B-04987815005702
Reference: CAFL0570
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Adeno Neo Test Plate 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815003715
Basic UDI-DI: B-04987815003715
Reference: CAAD0371
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Adeno Neo 20T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815003708
Basic UDI-DI: B-04987815003708
Reference: CAAD0370
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Determine

Determine HIV Controls

IVD Annex II List AIVDDOn the marketHuman tissuesNear-patient testingProfessional testing

Manufacturer: Abbott Diagnostics Medical Co., Ltd.
Manufacturer SRN: JP-MF-000009543
UDI-DI: 04571226474747
Basic UDI-DI: B-04571226474747
Reference: 7D2253
EMDN: W0105094002
EMDN description: STANDARDS AND CALIBRATORS INFECTIOUS IMMUNOLOGY/NAT - RT & POC
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

04571226473832

Determine HIV Early Detect

IVD Annex II List AIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingSingle use

Manufacturer: Abbott Diagnostics Medical Co., Ltd.
Manufacturer SRN: JP-MF-000009543
UDI-DI: 04571226473832
Basic UDI-DI: B-04571226473832
Reference: 7D2846
EMDN: W0105090303
EMDN description: HIV AG/AB COMBI - RT & POC
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

TestPack Plus Strep A with OBC

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: Abbott Diagnostics Medical Co., Ltd.
Manufacturer SRN: JP-MF-000009543
UDI-DI: 04571226471784
Basic UDI-DI: B-04571226471784
Reference: 505715J
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

Determine

Determine Syphilis TP

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingSingle use

Manufacturer: Abbott Diagnostics Medical Co., Ltd.
Manufacturer SRN: JP-MF-000009543
UDI-DI: 04571226470206
Basic UDI-DI: B-04571226470206
Reference: 7D2443
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0628U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001679
Basic UDI-DI: B-00608337001679
Reference: 1001-0628U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Poland
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0603U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001532
Basic UDI-DI: B-00608337001532
Reference: 1001-0603U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0630U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001068
Basic UDI-DI: B-00608337001068
Reference: 1001-0630U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0627U

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337001662
Basic UDI-DI: B-00608337001662
Reference: 1001-0627U
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 10:01

Manufacturer products Authorised representative products Authorised representative actors View details