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LDBIO TOXO II IgG

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

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: 37700277931994
Basic UDI-DI: 3770027793WBT2G7F
Reference: TOXO II 12G
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: France
Authorised representative: -
Last updated: 24.09.2026 04:06

Manufacturer products View details

SeraSpot® Anti-Borrelia IgM

Sera Spot® Anti-Borrelia IgM

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

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301833
Basic UDI-DI: 4099466SP018MVU
Reference: SP-018 M-S6
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 04:02

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SeraSpot® Anti-Borrelia IgG

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

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301819
Basic UDI-DI: 4099466SP018GVG
Reference: SP-018 G-S6
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 04:02

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SARS-CoV-2 Antigen Rapid Test

25 Tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910000
Basic UDI-DI: B-06979890910000
Reference: 25 Tests
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Greece
Authorised representative: Llins Service & Consulting GmbH
Last updated: 24.09.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

RealTime

ABBOTT REALTIME MTB RIF/INH RESISTANCE

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00884999038738
Basic UDI-DI: 0884999RTN0828BR
Reference: 08N28-080
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 02:51

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RealTime

ABBOTT REALTIME MTB

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00884999037694
Basic UDI-DI: 0884999RTN0815BG
Reference: 08N15-080
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 02:51

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RealTime

ABBOTT REALTIME CMV

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999014749
Basic UDI-DI: 0884999RTN0523AY
Reference: 5N23-70
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 24.09.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

RealTime

ABBOTT REALTIME CT/NG

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999001442
Basic UDI-DI: 0884999RTG02288E
Reference: 2G28-80
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 24.09.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur HBsAgII

IVDR_67_TTN_DUB-C_D_KIT_HBsAgII

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414578170
Basic UDI-DI: 0405686901882WE
Reference: 10492138
EMDN: W0105020211
EMDN description: HEPATITIS B ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): SSP_ADVIA Centaur_HBsAgII_HBsAg Conf_QC · Rev. 10.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.09.2026 02:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Alinity

HSV-1 IgG

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

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740196431
Basic UDI-DI: 038074AIW0420MU
Reference: 04W2025
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Ireland
Authorised representative: -
Last updated: 24.09.2026 02:11

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Alinity

Alinity i Toxo IgG Avidity

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740131166
Basic UDI-DI: 038074AIP0746LG
Reference: 07P4610
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 02:10

Manufacturer products View details

ARCHITECT

ARCHITECT Toxo IgG Avidity

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740011338
Basic UDI-DI: 038074ARL0637NK
Reference: 06L3711
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 02:09

Manufacturer products View details

P0266 ViraQ Parvo B19/HAV Check

IVD Class BIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: Biologicals Quality Control B.V.
Manufacturer SRN: NL-MF-000026798
UDI-DI: 08718719830536
Basic UDI-DI: 871871983P0266F3
Reference: P0266/03
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Netherlands
Authorised representative: -
Last updated: 24.09.2026 01:33

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P0264 ViraQ HEV Check 125

IVD Class BIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: Biologicals Quality Control B.V.
Manufacturer SRN: NL-MF-000026798
UDI-DI: 08718719830512
Basic UDI-DI: 871871983P0264EX
Reference: P0264/03
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Netherlands
Authorised representative: -
Last updated: 24.09.2026 01:33

Manufacturer products View details

P0048 ViraQ Negative

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingSingle use

Manufacturer: Biologicals Quality Control B.V.
Manufacturer SRN: NL-MF-000026798
UDI-DI: 08718719830482
Basic UDI-DI: 871871983P0048EP
Reference: P0048/01
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Netherlands
Authorised representative: -
Last updated: 24.09.2026 01:33

Manufacturer products View details

P0247 ViraQ WNV Check 125

IVD Class BIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: Biologicals Quality Control B.V.
Manufacturer SRN: NL-MF-000026798
UDI-DI: 08718719830406
Basic UDI-DI: 871871983P0247EX
Reference: P0247/03
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Netherlands
Authorised representative: -
Last updated: 24.09.2026 01:33

Manufacturer products View details

P0318 ViraQ HIV-2 Check 125

IVD Class BIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: Biologicals Quality Control B.V.
Manufacturer SRN: NL-MF-000026798
UDI-DI: 08718719830307
Basic UDI-DI: 871871983P0318EV
Reference: P0318/02
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Netherlands
Authorised representative: -
Last updated: 24.09.2026 01:32

Manufacturer products View details

ChainFor™

Neisseria meningitidis Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277341
Basic UDI-DI: 868499827PCR113YH
Reference: CFP113P50
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:25

Manufacturer products View details

ChainFor™

H.pylori/Clarithromycin Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276405
Basic UDI-DI: 868511580PCR144GP
Reference: CFP144P50
EMDN: W0105050399
EMDN description: OTHER PARASITOLOGY - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:25

Manufacturer products View details

LyoSens™

CMV Quantitative qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275095
Basic UDI-DI: 868499827PCR109YS
Reference: LYO109WS24
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:25

Manufacturer products View details