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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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NukEx Mag RNA/DNA

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IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: gerbion GmbH & Co. KG
Manufacturer SRN: DE-MF-000021421
UDI-DI: 04260199010112
Basic UDI-DI: 426019901G05012JD
Reference: G05012-800
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 16:31

Manufacturer products View details

alphaClean Mag RNA/DNA

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IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: gerbion GmbH & Co. KG
Manufacturer SRN: DE-MF-000021421
UDI-DI: 04262381760515
Basic UDI-DI: 426019901G05012JD
Reference: 831002
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 16:31

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alphaClean Mag RNA/DNA

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IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: gerbion GmbH & Co. KG
Manufacturer SRN: DE-MF-000021421
UDI-DI: 04262381760522
Basic UDI-DI: 426019901G05012JD
Reference: 831028
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 16:31

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RSV/ADV Rapid Antigen Test

RSV/ADV Rapid Antigen Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349148112
Basic UDI-DI: 697334914RJ07MC
Reference: RJ07-1
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 23.09.2026 16:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Rapid Antigen Test

Influenza A&B Rapid Antigen Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349148068
Basic UDI-DI: 697334914RJ05M8
Reference: RJ05-1
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 23.09.2026 16:26

Manufacturer products Authorised representative products Authorised representative actors View details

Bone & Joint Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214529794
Basic UDI-DI: 868521452PCR196GT
Reference: CFP196P100
EMDN: W0105070201
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:32

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Wound Infection Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214529596
Basic UDI-DI: 868521452PCR197GV
Reference: CFP197P100
EMDN: W0105070201
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:32

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Nail Infections Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214529381
Basic UDI-DI: 868521452PCR198GX
Reference: CFP198P100
EMDN: W0105060499
EMDN description: MYCOLOGY NA REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:32

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Tropical Fever Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214529206
Basic UDI-DI: 868521452PCR199GZ
Reference: CFP199P100
EMDN: W0105070506
EMDN description: TROPICAL FEVER - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:32

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Cryptococcus gatti/neoformans qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214529183
Basic UDI-DI: 868521452PCR186GQ
Reference: LYO186WS24
EMDN: W0105060303
EMDN description: CRYPTOCOCCUS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:32

Manufacturer products View details

Fever and Rash Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214529039
Basic UDI-DI: 868521452PCR200FR
Reference: CFP200P100
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:31

Manufacturer products View details

LYO185WS24

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214528889
Basic UDI-DI: 868521452PCR185GN
Reference: LYO185WS24
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:31

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HPV 16/18/45 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214527851
Basic UDI-DI: 868521452PCR206G5
Reference: CFP206P100
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:31

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HHV-8 qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214528957
Basic UDI-DI: 868521452PCR195GR
Reference: CFP195P25
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:31

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Pneumocystis jirovecii qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039861
Basic UDI-DI: 868521452PCR98JN
Reference: LYO98WS48
EMDN: W0105060405
EMDN description: PNEUMOCYSTIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:31

Manufacturer products View details

LYO190WS24

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214528841
Basic UDI-DI: 868521452PCR190GF
Reference: CFP190P100
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:23

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JCV Quantitative qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214528681
Basic UDI-DI: 868521452PCR192GK
Reference: LYO192WS24
EMDN: W0105040523
EMDN description: JC VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:23

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Aspergillus/Fusarium/Trichosporon Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214528667
Basic UDI-DI: 868521452PCR193GM
Reference: CFP193P100
EMDN: W0105060499
EMDN description: MYCOLOGY NA REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:23

Manufacturer products View details

HHV-6/HHV-7 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214528483
Basic UDI-DI: 868521452PCR194GP
Reference: CFP194P100
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:23

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Pneumocystis jirovecii/Staphylococcus aureus Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214528124
Basic UDI-DI: 868521452PCR182GG
Reference: LYO182WS24
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 14:23

Manufacturer products View details