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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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D-1076P

Creatine Kinase Kit (NAC Method)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-1076P
Basic UDI-DI: B-1076P
Reference: /
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 03:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-1066M

High Density Lipoprotein Cholesterol Kit (Enzyme Clearance Assay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-1066M
Basic UDI-DI: B-1066M
Reference: /
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 02:48

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0629

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001683
Basic UDI-DI: B-10608337001683
Reference: 1001-0629
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Cyprus
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 02:20

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0602

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001522
Basic UDI-DI: B-10608337001522
Reference: 1001-0602
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 02:20

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

1001-0274

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

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337000563
Basic UDI-DI: B-10608337000563
Reference: 1001-0274
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 02:20

Manufacturer products Authorised representative products Authorised representative actors View details

Test autodiagnostico Celiachia

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-101177LK
Basic UDI-DI: B-101177LK
Reference: 101177-x
EMDN: W0102100604
EMDN description: GLIADIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

PRIMA HOME TEST

100077-x

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-100077-1CSXZ
Basic UDI-DI: B-100077-1CSXZ
Reference: 100077-1CS
EMDN: W0102100699
EMDN description: CELIAC DISEASE - OTHER
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

PRIMA HOME TEST

100058-x

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-100058-3CSXU
Basic UDI-DI: B-100058-3CSXU
Reference: 100058-3CS
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

09349609001126

ARST001-04

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609001126
Basic UDI-DI: B-09349609001126
Reference: ARST001-04
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

09349609001140

ARST001-05

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609001140
Basic UDI-DI: B-09349609001140
Reference: ARST001-05
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

09349609001102

NFLD001-03

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609001102
Basic UDI-DI: B-09349609001102
Reference: NFLD001-03
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

09349609000969

IVD Annex II List ANot specifiedOn the marketSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000969
Basic UDI-DI: B-09349609000969
Reference: NFLD001-02
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

09349609000952

NFLD001-02

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000952
Basic UDI-DI: B-09349609000952
Reference: NFLD001-02
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Newfoundland HIV Self Test

NFLD001-01

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000938
Basic UDI-DI: B-09349609000938
Reference: NFLD001-01
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Simplitude ByMe

Galileo Platform

IVD Annex II List AIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000600
Basic UDI-DI: B-09349609000600
Reference: P003948A1-10
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Simplitude ByMe

Galileo Platform

IVD Annex II List AIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000204
Basic UDI-DI: B-09349609000204
Reference: P002514A1-10
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

09349609000082

ARST001-02

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle useSterile

Manufacturer: Atomo Diagnostics Limited
Manufacturer SRN: AU-MF-000024146
UDI-DI: 09349609000082
Basic UDI-DI: B-09349609000082
Reference: ARST001-02
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Truemix COVID-19

701430096

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139699
Basic UDI-DI: B-08908020139699
Reference: 701430096
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truemix COVID-19

701430048

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139682
Basic UDI-DI: B-08908020139682
Reference: 701430048
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truemix COVID-19

701430024

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139675
Basic UDI-DI: B-08908020139675
Reference: 701430024
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details