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Helicobacter ViraChip IgG Positive Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRHPCGPK1
Basic UDI-DI: ++EVIRHelicobacterContrLU
Reference: V-HPCGPK
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:46

Manufacturer products View details

Helicobacter ViraChip IgG,A,M Negative Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRHPCPNK1
Basic UDI-DI: ++EVIRHelicobacterContrLU
Reference: V-HPCPNK
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:46

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Borrelia All-In-One ViraChip Positive Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRBTCFPK1
Basic UDI-DI: ++EVIRLymeControl6T
Reference: V-BTCFPK
EMDN: W0105010602
EMDN description: LYME ANTIBODY TOTAL
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:45

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Borrelia ViraChip IgG,A,M Negative Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRBSCPNK1
Basic UDI-DI: ++EVIRLymeIgGControlMV
Reference: V-BSCPNK
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:45

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Bordetella pertussis ViraChip IgG Antigen Coated Wells

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRBPCGAC1
Basic UDI-DI: ++EVIRBordetellaABQH
Reference: V-BPCGAC
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:44

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Yersinia ViraChip IgA,IgM Antigen Coated Wells

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRYSCNAC1
Basic UDI-DI: ++EVIRYersiniaABSY
Reference: V-YSCNAC
EMDN: W0105011706
EMDN description: YERSINIA
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:44

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Helicobacter ViraChip IgG Antigen Coated Wells

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRHPCGAC1
Basic UDI-DI: ++EVIRHelicobacterABYG
Reference: V-HPCGAC
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:44

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Borrelia All-In-One ViraChip AP-Anti-Human Conjugate

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRBTCFKI1
Basic UDI-DI: ++EVIRLymeABCF
Reference: V-BTCFKI
EMDN: W0105010602
EMDN description: LYME ANTIBODY TOTAL
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:44

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RapidFor™

VMD82

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030370
Basic UDI-DI: 868459503VMD82SC49
Reference: VMD82SC
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 21:33

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RapidFor™

IVD Class BNot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277822
Basic UDI-DI: 868459503VMD82SC49
Reference: VMD82SD
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:33

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RapidFor™

IVD Class BNot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277839
Basic UDI-DI: 868459503VMD82SC49
Reference: VMD82BC
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:33

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RapidFor™

VMD27

IVD Class CIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941339
Basic UDI-DI: 868334794VMD27TD4B
Reference: VMD27TD
EMDN: W0105011001
EMDN description: SALMONELLA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 20:43

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S. TYPHI H

ANTIGENOS FEBRILES: S. typhi H

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155002984
Basic UDI-DI: B-18430155002984
Reference: 990188
EMDN: W0105011099
EMDN description: SALMONELLA REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.08.2026 22:50

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S. PARATYPHI A H

ANTIGENOS FEBRILES: S. paratyphi A, H

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155003790
Basic UDI-DI: B-18430155003790
Reference: 999917
EMDN: W0105011099
EMDN description: SALMONELLA REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.08.2026 22:50

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HelicoSign Dry

HPYD050

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076700451
Basic UDI-DI: B-08800076700451
Reference: HPYD050
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 12.08.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

res3plex direct PCR

res1plex direct PCR

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: FRIZ Biochem GmbH
Manufacturer SRN: DE-MF-000017533
UDI-DI: 04260753890280
Basic UDI-DI: 426075389fbc121TY
Reference: FBC121
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 11.08.2026 23:49

Manufacturer products View details

res2plex direct PCR

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: FRIZ Biochem GmbH
Manufacturer SRN: DE-MF-000017533
UDI-DI: 04260753890273
Basic UDI-DI: 426075389fbc120TW
Reference: FBC120
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 11.08.2026 23:49

Manufacturer products View details

Salmonella typhi Antigen Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISTY-602W7
Basic UDI-DI: B-ISTY-602W7
Reference: ISTY-602
EMDN: W0105011001
EMDN description: SALMONELLA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 10.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

RealAccurate® Quadruplex Mycobacteria PCR kit

PF0920-R

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719326569963
Basic UDI-DI: B-08719326569963
Reference: PF0920-R
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

MeningoFinder® 2SMART

PF1200-2S

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719327116111
Basic UDI-DI: B-08719327116111
Reference: PF1200-2S
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details