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EBV ELITe Standard

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: ElitechGroup S.p.A.
Manufacturer SRN: IT-MF-000005919
UDI-DI: 08033891483661
Basic UDI-DI: 803389148EBV20A2
Reference: https://www.elitechgroup.com/documentation/
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 22:51

Manufacturer products View details

VitaPCR SARS-CoV-2 External Control Set

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570176
Basic UDI-DI: B-04719878570176
Reference: PCRAE0115
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR SARS-CoV-2 Gen 2 External Control Set

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570428
Basic UDI-DI: B-04719878570428
Reference: PCRAE0135
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Flu A&B External Control Set

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570435
Basic UDI-DI: B-04719878570435
Reference: PCRAE0136
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR RSV External Control Set

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570442
Basic UDI-DI: B-04719878570442
Reference: PCRAE0137
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo SARS-CoV-2/Flu/RSV External Control Set

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570534
Basic UDI-DI: B-04719878570534
Reference: PCRAD1106
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

Bacterial Antigen polyvalent control -

5902

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035102114
Basic UDI-DI: B-05404035102114
Reference: 5902
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:37

Manufacturer products View details

Bacterial Antigen polyvalent control +

5901

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035102107
Basic UDI-DI: B-05404035102107
Reference: 5901
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:37

Manufacturer products View details

AMPLIRUN® ENTEROVIRUS 68 RNA CONTROL

MBC125

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040328057
Basic UDI-DI: 843604032MBC125012R
Reference: MBC125
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

Manufacturer products View details

AMPLIRUN® PARAINFLUENZA 4 A RNA CONTROL

MBC050

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322468
Basic UDI-DI: 843604032MBC050012A
Reference: MBC050
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

AMPLIRUN® TREPONEMA PALLIDUM DNA CONTROL

MBC109

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322666
Basic UDI-DI: 843604032MBC109012X
Reference: MBC109
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

AMPLIRUN® RHINOVIRUS RNA CONTROL

MBC091

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322390
Basic UDI-DI: 843604032MBC091013B
Reference: MBC091
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

AMPLIRUN® RESPIRATORY SYNCYTIAL VIRUS (B) RNA CONTROL

MBC083

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322314
Basic UDI-DI: 843604032MBC083013E
Reference: MBC083
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

AMPLIRUN® TRICHOMONAS VAGINALIS DNA CONTROL

MBC079

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322291
Basic UDI-DI: 843604032MBC0790145
Reference: MBC079
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

AMPLIRUN® NOVEL INFLUENZA A H1N1 RNA CONTROL

MBC082

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322208
Basic UDI-DI: 843604032MBC0820139
Reference: MBC082
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

AMPLIRUN® NEISSERIA GONORRHOEAE DNA CONTROL

MBC075

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322185
Basic UDI-DI: 843604032MBC075013H
Reference: MBC075
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

AMPLIRUN® EPSTEIN-BARR VIRUS DNA CONTROL

MBC065

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322147
Basic UDI-DI: 843604032MBC065013A
Reference: AMPLIRUN® EPSTEIN-BARR VIRUS DNA CONTROL
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

AMPLIRUN® INFLUENZA A H5 RNA CONTROL

MBC052

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322017
Basic UDI-DI: 843604032MBC052012L
Reference: MBC052
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

AMPLIRUN® VARICELLA-ZOSTER VIRUS DNA CONTROL

MBC048

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040321973
Basic UDI-DI: 843604032MBC048013B
Reference: MBC048
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

AMPLIRUN® TOXOPLASMA GONDII DNA CONTROL

MBC047

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040321966
Basic UDI-DI: 843604032MBC0470136
Reference: MBC047
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details