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24 device results listed.

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MONO Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104951
Basic UDI-DI: 6970277510000KXX
Reference: IMO-N402-25
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-IMO-402U8

MONO Rapid Test Cassette (WB/S/P)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-IMO-402U8
Basic UDI-DI: B-IMO-402U8
Reference: IMO-402
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

MONO Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMO-R402HR
Basic UDI-DI: B-IMO-R402HR
Reference: IMO-R402
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir04038BX

Norovirus GI/GII Antigen Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir04038BX
Basic UDI-DI: B-697994388Ir04038BX
Reference: Ir040
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL® Mononucleosis Test

Mononucleosis Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-252003N-20UR
Basic UDI-DI: B-nvm-252003N-20UR
Reference: 252003N-20
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

Mononucleosis Rapid Test

VIMO-401

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIMO-401RX
Basic UDI-DI: B-VIMO-401RX
Reference: VIMO-401
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)

GCMON-425a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMON-425aHG9Q
Basic UDI-DI: B-GCMON-425aHG9Q
Reference: GCMON-425a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCMON-425a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMON-425a7C
Basic UDI-DI: B-GCMON-425a7C
Reference: GCMON-425a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCMON-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMON-402aHG8D
Basic UDI-DI: B-GCMON-402aHG8D
Reference: GCMON-402a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCMON-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMON-402a6R
Basic UDI-DI: B-GCMON-402a6R
Reference: GCMON-402a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/lgM Rapid Test Cassette(Serum/Plasma)

GCMON-325a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMON-325aHG9B
Basic UDI-DI: B-GCMON-325aHG9B
Reference: GCMON-325a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/IgM Rapid Test Cassette (Serum/Plasma)

GCMON-325a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMON-325a75
Basic UDI-DI: B-GCMON-325a75
Reference: GCMON-325a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

EBNA IgG Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601320
Basic UDI-DI: B-16972698601320
Reference: P231117
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

EBV-VCA IgG Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601313
Basic UDI-DI: B-16972698601313
Reference: P231116
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosi Infettiva

7746

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: GIESSE DIAGNOSTICS SRL
Manufacturer SRN: IT-MF-000039031
UDI-DI: 08053172971533
Basic UDI-DI: B-08053172971533
Reference: 7746
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:46

Manufacturer products View details

MONO Rapid Test

GIMONO

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763217
Basic UDI-DI: B-06976202763217
Reference: GIMONO-402
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis Test

GIMONO

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762524
Basic UDI-DI: B-06976202762524
Reference: GIMONO-402
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Prueba Rápida de Mononucleosis en Casete

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983126212
Basic UDI-DI: B-06936983126212
Reference: IMO-402
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

monogen kit 50 tests

Monogen

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950001676
Basic UDI-DI: 84269500016764Y
Reference: 3000-1001
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:02

Manufacturer products View details

05902643958579

Mononucleosis 25 tests

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958579
Basic UDI-DI: 59026439BRT345JS
Reference: 1-345-K025
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:27

Manufacturer products View details