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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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24.09.2026 23:03

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One Step Syphilis Anti-TP Test (Colloidal Gold)

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700408829
Basic UDI-DI: 697029753446LW
Reference: HGCG10
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 05:35

Manufacturer products Authorised representative products Authorised representative actors View details

LYO144WS96

IVD Class CIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115807519
Basic UDI-DI: 868511580PCR144GP
Reference: LYO144WS96
EMDN: W0105010403
EMDN description: H. PYLORI DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 05:11

Manufacturer products View details

CFP44

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257468
Basic UDI-DI: 868511580PCR102G7
Reference: CFP102P100
EMDN: W0105011606
EMDN description: YERSINIA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 04:18

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999037359
Basic UDI-DI: 0884999RTG02288E
Reference: 2G28-67
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Abbott GmbH
Last updated: 22.09.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999001466
Basic UDI-DI: 0884999RTG02288E
Reference: 2G28-91
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: Abbott GmbH
Last updated: 22.09.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

Bordetella pertussis ViraChip IgA Test Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRBPCAOK1
Basic UDI-DI: ++EVIRBordetellaKit2D
Reference: V-BPCAOK
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:18

Manufacturer products View details

Bordetella pertussis ViraChip IgG Test Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRBPCGOK1
Basic UDI-DI: ++EVIRBordetellaKit2D
Reference: V-BPCGOK
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:18

Manufacturer products View details

Bordetella pertussis ViraChip IgG Deca Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRBPCGDK1
Basic UDI-DI: ++EVIRBordetellaKit2D
Reference: V-BPCGDK
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:18

Manufacturer products View details

Yersinia ViraChip IgA Test Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRYSCAOK1
Basic UDI-DI: ++EVIRYersiniaKitK3
Reference: V-YSCAOK
EMDN: W0105011706
EMDN description: YERSINIA
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:17

Manufacturer products View details

Yersinia ViraChip IgG Deca Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRYSCGDK1
Basic UDI-DI: ++EVIRYersiniaKitK3
Reference: V-YSCGDK
EMDN: W0105011706
EMDN description: YERSINIA
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:17

Manufacturer products View details

Yersinia ViraChip IgG Test Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRYSCGOK1
Basic UDI-DI: ++EVIRYersiniaKitK3
Reference: V-YSCGOK
EMDN: W0105011706
EMDN description: YERSINIA
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:17

Manufacturer products View details

Helicobacter ViraChip IgA Test Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRHPCAOK1
Basic UDI-DI: ++EVIRHelicobacterKitPE
Reference: V-HPCAOK
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:16

Manufacturer products View details

Helicobacter ViraChip IgG Test Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRHPCGOK1
Basic UDI-DI: ++EVIRHelicobacterKitPE
Reference: V-HPCGOK
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:16

Manufacturer products View details

Helicobacter ViraChip IgG Deca Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRHPCGDK1
Basic UDI-DI: ++EVIRHelicobacterKitPE
Reference: V-HPCGDK
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:16

Manufacturer products View details

Borrelia ViraChip IgG Test Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRBSCGOK1
Basic UDI-DI: ++EVIRLymeIgGKit2V
Reference: V-BSCGOK
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:16

Manufacturer products View details

Borrelia ViraChip IgM Test Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRBSCMOK1
Basic UDI-DI: ++EVIRLymeIgMKit47
Reference: V-BSCMOK
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:15

Manufacturer products View details

Borrelia All-In-One ViraChip Test Kit

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IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRBTCFOK1
Basic UDI-DI: ++EVIRLymeKit4H
Reference: V-BTCFOK
EMDN: W0105010602
EMDN description: LYME ANTIBODY TOTAL
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:15

Manufacturer products View details

C. DIFF QUIK CHEK COMPLETE

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: TECHLAB, Inc.
Manufacturer SRN: US-MF-000008412
UDI-DI: 00857031002059
Basic UDI-DI: 857031002CDIFFAGTOX001SJ
Reference: T30525C
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 22.09.2026 03:11

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115808745
Basic UDI-DI: 868511580PCR67JS
Reference: LYO67WS48
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:41

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998273589
Basic UDI-DI: 868459503VMPO119STSVN
Reference: VMPO119TTS
EMDN: W0105010107
EMDN description: CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:36

Manufacturer products View details