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Alinity m

ALINITY M CMV

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999049567
Basic UDI-DI: 0884999AMN0946XZ
Reference: 09N46-070
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

ALINITY M SARS-COV-2

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999049192
Basic UDI-DI: 0884999AMN0006W8
Reference: 09N78-080
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

ALINITY M HR HPV

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999047914
Basic UDI-DI: 0884999AMN0915XN
Reference: 09N15-080
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

80845357043708

ABT-001

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 80845357043708
Basic UDI-DI: 08453570ABT-0014T
Reference: [ABT-001] QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

10845357043570

HE0066NS

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043570
Basic UDI-DI: 08453570HE0066NS32
Reference: [HE0066NS] Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Swab)
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

10845357043563

HE0065N

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043563
Basic UDI-DI: 08453570HE0065NZF
Reference: [HE0065N] Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Pellet)
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

OnSite® Dengue Ag Rapid Test

R0063C

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

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114460023
Basic UDI-DI: 081011446R0063CDU
Reference: R0063C
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Rubella M

IVDR_67_TTN_DUB-C_C_REAG_KIT_Rubella M

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414201436
Basic UDI-DI: 0405686901822VU
Reference: 10310285
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Rubella G assay

IVDR_67_TTN_DUB-C_C_REAG_Rub G assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414201412
Basic UDI-DI: 0405686902036V6
Reference: 10310283
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 EBV-VCA IgM

IVDR_67_LLB_DUB-C_B_KIT_EBV-VCA IgM

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414999845
Basic UDI-DI: 0405686901377VU
Reference: 10488005
EMDN: W010504040104
EMDN description: EBV VCA IGM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Rubella Quantitative IgG

IVDR_67_LLB_DUB-C_C_REAG_KIT_Rubella Quantitative IgG

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962061
Basic UDI-DI: 0405686901462VL
Reference: 10381305
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Rubella IgM

IVDR_67_LLB_DUB-C_C_KIT_Rubella IgM

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961996
Basic UDI-DI: 0405686901461VJ
Reference: 10381327
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 CMV IgM

IVDR_67_LLB_DUB-C_C_KIT_CMV IgM

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961163
Basic UDI-DI: 0405686901445VL
Reference: 10381320
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 EBV-VCA IgG

IVDR_67_LLB_DUB-C_B_KIT_EBV-VCA IgG

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414999876
Basic UDI-DI: 0405686900225UV
Reference: 10381330
EMDN: W010504040105
EMDN description: EBV VCA IGG
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 EBV-EBNA IgG

IVDR_67_LLB_DUB-C_B_KIT_EBV-EBNA IgG

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414999838
Basic UDI-DI: 0405686900224UT
Reference: 10381307
EMDN: W010504040106
EMDN description: EBV EBNA IGG
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

MAX

BD Respiratory Viral Panel for BD MAX™ System

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904453732
Basic UDI-DI: 038290QOYRIOCFPE
Reference: 445373
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

112009491923

SwiftX Virus

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Xpedite Diagnostics GmbH
Manufacturer SRN: DE-MF-000020021
UDI-DI: 112009491923
Basic UDI-DI: PP12579SWIFTX.VIRUS30
Reference: SXV-50-IVD
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:39

Manufacturer products View details

111917795923

EUROArray SwiftX-traction

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Xpedite Diagnostics GmbH
Manufacturer SRN: DE-MF-000020021
UDI-DI: 111917795923
Basic UDI-DI: PP12579SWIFTX.EUROARRAY49
Reference: SXEA-50-IVD
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:38

Manufacturer products View details

D-ZDC-K-0014D

ZDC-K-001

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Co-Diagnostics, Inc.
Manufacturer SRN: US-MF-000036425
UDI-DI: D-ZDC-K-0014D
Basic UDI-DI: B-ZDC-K-0014D
Reference: ZDC-K-001
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Varicella-zoster Virus/Variola Virus Real Time PCR Kit

YJC70303NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-YJC70303NW-50T58
Basic UDI-DI: B-YJC70303NW-50T58
Reference: YJC70303NW-50T
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details