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GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161951551
Basic UDI-DI: B-08594161951551
Reference: HSV/ISEX/025
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 04:29

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H. pylori Ag MonlabTest

MO-804001 25 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: MONLAB SL
Manufacturer SRN: ES-MF-000001438
UDI-DI: 08436539090496
Basic UDI-DI: B-08436539090496
Reference: MO-804001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 04:25

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TETANUS ELISA IgG

G1008

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320501
Basic UDI-DI: B-08436040320501
Reference: G1008
EMDN: W0105011709
EMDN description: TETANUS (CLOSTRIDIUM T.)
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:18

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TOXOPLASMA ELISA IgG

G1027

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320518
Basic UDI-DI: B-08436040320518
Reference: G1027
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:18

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SYPHILIS ELISA IgG

G1060

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320488
Basic UDI-DI: B-08436040320488
Reference: G1060
EMDN: W0105010303
EMDN description: SYPHILIS ANTIBODY IGG
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:18

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RUBELLA ELISA IgM CAPTURE

M1026

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320457
Basic UDI-DI: B-08436040320457
Reference: M1026
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:18

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RUBELLA ELISA IgG

G1026

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320440
Basic UDI-DI: B-08436040320440
Reference: G1026
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

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RICKETTSIA CONORII ELISA IgG/IgM

G/M1005

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320433
Basic UDI-DI: B-08436040320433
Reference: G/M1005
EMDN: W0105011705
EMDN description: RICKETTSIA
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

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RESPIRATORY SYNCYTIAL VIRUS ELISA IgG/IgM

G/M1006

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320426
Basic UDI-DI: B-08436040320426
Reference: G/M1006
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

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PARAINFLUENZA 3 ELISA IgG/IgM

G/M1011

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320389
Basic UDI-DI: B-08436040320389
Reference: G/M1011
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

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PARAINFLUENZA 2 ELISA IgG/IgM

G/M1010

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320372
Basic UDI-DI: B-08436040320372
Reference: G/M1010
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

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PARAINFLUENZA 1 ELISA IgG/IgM

G/M1009

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320365
Basic UDI-DI: B-08436040320365
Reference: G/M1009
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

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MYCOPLASMA PNEUMONIAE ELISA IgG/IgM

G/M1015

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320358
Basic UDI-DI: B-08436040320358
Reference: G/M1015
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

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MYCOPLASMA PNEUMONIAE ELISA IgG

G1002

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320341
Basic UDI-DI: B-08436040320341
Reference: G1002
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

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MYCOPLASMA PNEUMONIAE ELISA IgM

M1002

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320334
Basic UDI-DI: B-08436040320334
Reference: M1002
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

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MUMPS ELISA IgG/IgM

G/M1014

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320327
Basic UDI-DI: B-08436040320327
Reference: G/M1014
EMDN: W0105040801
EMDN description: MUMPS / PAROTITIS VIRUS ANTIBODIES - TOTAL
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

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MEASLES ELISA IgG/IgM

G/M1001

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320310
Basic UDI-DI: B-08436040320310
Reference: G/M1001
EMDN: W0105040701
EMDN description: MEASLES VIRUS ANTIBODIES - TOTAL
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

LEGIONELLA PNEUMOPHILA SEROGROUP 1 ELISA IgM

M1000

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320280
Basic UDI-DI: B-08436040320280
Reference: M1000
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

LEGIONELLA PNEUMOPHILA SEROGROUP 1 ELISA IgG

G1000

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320273
Basic UDI-DI: B-08436040320273
Reference: G1000
EMDN: W0105010502
EMDN description: LEGIONELLA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

INFLUENZA B ELISA IgG/IgM

G/M1008

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320266
Basic UDI-DI: B-08436040320266
Reference: G/M1008
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details