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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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mariPOC® SARS-CoV-2 test reagent

mariPOC® SARS-CoV-2 test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R13EL
Basic UDI-DI: B-1R13EL
Reference: 1R13
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Finland
Authorised representative: -
Last updated: 21.09.2026 23:23

Manufacturer products View details

Helix Elite™ Molecular Standards: Inactivated Standard

-

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043266
Basic UDI-DI: 08453570HE0057NZG
Reference: [HE0057N] Helix Elite™ Molecular Standards Human Papillomavirus 18 (HPV 18) Cellularity Control (Inactivated Pellet)
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 21.09.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

Helix Elite™ Molecular Standards: Inactivated Standard

-

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042139
Basic UDI-DI: 08453570HE0039NZC
Reference: [HE0039N] Helix Elite™ Molecular Standards Inactivated Cytomegalovirus Low Control Strain AD-169
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 21.09.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

Helix Elite™ Molecular Standards: Inactivated Standard

-

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042122
Basic UDI-DI: 08453570HE0038NZ9
Reference: [HE0038N] Helix Elite™ Molecular Standards Inactivated Varicella Zoster Virus Strain VZ-10
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 21.09.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

4564879001

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00810124272807
Basic UDI-DI: B-00810124272807
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

4564859000

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00810124272784
Basic UDI-DI: B-00810124272784
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

4564849001

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00810124272777
Basic UDI-DI: B-00810124272777
Reference: IST-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

4564839001

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00810124272760
Basic UDI-DI: B-00810124272760
Reference: IST-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

4564829000

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00810124272753
Basic UDI-DI: B-00810124272753
Reference: IST-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

4564819001

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00810124272746
Basic UDI-DI: B-00810124272746
Reference: IMO-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

4564809001

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00810124272739
Basic UDI-DI: B-00810124272739
Reference: IMO-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

4564799000

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00810124272722
Basic UDI-DI: B-00810124272722
Reference: IMO-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

4564789015

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00810124272715
Basic UDI-DI: B-00810124272715
Reference: IMO-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 + FLU A/B + RSV + ADV + MP Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274364
Basic UDI-DI: 868354825VMD81SC3B
Reference: VMD81TD
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 22:50

Manufacturer products View details

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274371
Basic UDI-DI: 868354825VMD81SC3B
Reference: VMD81SD
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 22:50

Manufacturer products View details

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274388
Basic UDI-DI: 868354825VMD81SC3B
Reference: VMD81BC
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 22:50

Manufacturer products View details

VMD80

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548253514
Basic UDI-DI: 868354825VMD80SC36
Reference: VMD80SC
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:50

Manufacturer products View details

SARS-CoV-2 + RSV Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274333
Basic UDI-DI: 868354825VMD80SC36
Reference: VMD80TD
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 22:50

Manufacturer products View details

SARS-CoV-2 + RSV Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274340
Basic UDI-DI: 868354825VMD80SC36
Reference: VMD80SD
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 22:50

Manufacturer products View details

SARS-CoV-2 + RSV Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274357
Basic UDI-DI: 868354825VMD80SC36
Reference: VMD80BC
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 22:50

Manufacturer products View details