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COVID-19/Influenza A+B Antigen Combo Rapid Test

ICFq325, ICFq328

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICFq32GX
Basic UDI-DI: B-ICFq32GX
Reference: ICFq325, ICFq328
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Influenza A+B Antigen Combo Rapid Test

ICFq312, ICFq318

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICFq31GV
Basic UDI-DI: B-ICFq31GV
Reference: ICFq312, ICFq318
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

Bordetella pertussis Antigen Rapid Test

B-IBP-ACO502VN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IBP-ACO502VN
Basic UDI-DI: B-IBP-ACO502VN
Reference: IBP-ACO502
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Lithuania
Authorised representative: VidaQuick Biotech S.L.
Last updated: 07.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test (Swab)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IADq00FE
Basic UDI-DI: B-IADq00FE
Reference: IADq001, IADq002, IADq008
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test (Feces)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IAD60075
Basic UDI-DI: B-IAD60075
Reference: IAD6001, IAD6002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Herpes simplex virus-2 lgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859547
Basic UDI-DI: B-06933289859547
Reference: WA92P0002
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Herpes simplex virus-2 lgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859530
Basic UDI-DI: B-06933289859530
Reference: WA92P0001
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

Vector-borne Pathogen Panel Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849999
Basic UDI-DI: B-06933289849999
Reference: WR41P0010
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

04049198027013

Epstein-Barr Virus (VCA) IgG ELISA

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Demeditec Diagnostics GmbH
Manufacturer SRN: DE-MF-000012836
UDI-DI: 04049198027013
Basic UDI-DI: B-04049198027013
Reference: DEEBVG0150
EMDN: W010504040105
EMDN description: EBV VCA IGG
First on market country: Germany
Authorised representative: -
Last updated: 06.08.2026 23:20

Manufacturer products View details

LyoSens™

Legionella pneumoniae qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258472
Basic UDI-DI: 868511580PCR36JF
Reference: LYO36WS24
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 06.08.2026 23:03

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595038475
Basic UDI-DI: 868511580PCR36JF
Reference: LYO36WS48
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 23:03

Manufacturer products View details

LyoSens™

LYO36WS96

IVD Class CIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115800299
Basic UDI-DI: 868511580PCR36JF
Reference: LYO36WS96
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.08.2026 23:03

Manufacturer products View details

ChainFor™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031728
Basic UDI-DI: 868511580PCR36JF
Reference: CFP36P25
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 23:03

Manufacturer products View details

ChainFor™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033388
Basic UDI-DI: 868511580PCR36JF
Reference: CFP36P50
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 23:03

Manufacturer products View details

ChainFor™

CFP63

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257642
Basic UDI-DI: 868511580PCR36JF
Reference: CFP36P100
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.08.2026 23:03

Manufacturer products View details

VIASURE

VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD MAX™ System (2x12 tubes, 24 test)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440258704
Basic UDI-DI: 84354402MDXRESISTC_BMGMHP
Reference: 444224
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 23:01

Manufacturer products View details

VIASURE Macrolide resistance-associated mutations (23S rRNA) Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440241409
Basic UDI-DI: 84354402_MDXRESIST_MGRMZ
Reference: VS-MGR101L
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 23:01

Manufacturer products View details

VIASURE Macrolide resistance-associated mutations (23S rRNA) Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440241416
Basic UDI-DI: 84354402_MDXRESIST_MGRMZ
Reference: VS-MGR101H
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 23:01

Manufacturer products View details

VIASURE Macrolide resistance-associated mutations (23S rRNA) Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440241331
Basic UDI-DI: 84354402_MDXRESIST_MGRMZ
Reference: VS-MGR106H
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 23:01

Manufacturer products View details

VIASURE Macrolide resistance-associated mutations (23S rRNA) Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440241348
Basic UDI-DI: 84354402_MDXRESIST_MGRMZ
Reference: VS-MGR112L
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.08.2026 23:00

Manufacturer products View details