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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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1000+ device results listed.

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Mycoplasma pneumoniae Antigen Test Cassette

Mycoplasma pneumoniae Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-MP-502QN
Basic UDI-DI: B-ACO-MP-502QN
Reference: ACO-MP-502
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

HPIV Test Cassette

HPIV Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-HPIV-5024F
Basic UDI-DI: B-ACO-HPIV-5024F
Reference: ACO-HPIV-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

HMPV Test Cassette

HMPV Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-HMPV-5025P
Basic UDI-DI: B-ACO-HMPV-5025P
Reference: ACO-HMPV-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG, IgM and NS1 Combo Test Cassette

Dengue IgG, IgM and NS1 Combo Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-DEC-435FY
Basic UDI-DI: B-ACO-DEC-435FY
Reference: ACO-DEC-435
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

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Clostridium difficile GDH+Toxin A/B Test Cassette

Clostridium difficile GDH+Toxin A/B Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-CD-602GM
Basic UDI-DI: B-ACO-CD-602GM
Reference: ACO-CD-602
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Finland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus pneumoniae and RSV Combo Test Cassette

Adenovirus pneumoniae and RSV Combo Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-AR-502LG
Basic UDI-DI: B-ACO-AR-502LG
Reference: ACO-AR-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Cyprus
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus pneumoniae Antigen Test Cassette

Adenovirus pneumoniae Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-AD-502FN
Basic UDI-DI: B-ACO-AD-502FN
Reference: ACO-AD-502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Croatia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

Status COVID-19/Flu

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816001553
Basic UDI-DI: B-10743816001553
Reference: 33225
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0628

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001676
Basic UDI-DI: B-10608337001676
Reference: 1001-0628
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Poland
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0627

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001669
Basic UDI-DI: B-10608337001669
Reference: 1001-0627
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Bulgaria
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0603

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001539
Basic UDI-DI: B-10608337001539
Reference: 1001-0603
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0601

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001515
Basic UDI-DI: B-10608337001515
Reference: 1001-0601
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Portugal
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0600

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

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001270
Basic UDI-DI: B-10608337001270
Reference: 1001-0600
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HIV Self-Test

1001-0630

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337001065
Basic UDI-DI: B-10608337001065
Reference: 1001-0630
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 16:54

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics HBsAg ELISA 4.1

23470-480 (480 wells)

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581001006
Basic UDI-DI: B-08887581001006
Reference: 23470-480
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics ASSURE HEV lgM Rapid Test

MP Diagnostics ASSURE HEV lgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000702
Basic UDI-DI: B-08887581000702
Reference: 43160-020
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics MULTISURE HIV Rapid Test

MP Diagnostics MULTISURE HIV Rapid Test

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000665
Basic UDI-DI: B-08887581000665
Reference: 43030-020
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics HBsAg ELISA 4.1

23470-096 (96 wells)

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000610
Basic UDI-DI: B-08887581000610
Reference: 23470-096
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Influenza A&B qPCR Kit

RevoDx Influenza A&B qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717387
Basic UDI-DI: B-08683079717387
Reference: IP202220-500
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:22

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RevoDx Influenza A&B qPCR Kit

RevoDx Influenza A&B qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717370
Basic UDI-DI: B-08683079717370
Reference: IP202220-100
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:22

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