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Respiratory v2.0 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998273503
Basic UDI-DI: 868511580PCR102G7
Reference: CFP102P50
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:43

Manufacturer products View details

Respiratory v1.0 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998273497
Basic UDI-DI: 868511580PCR101G5
Reference: CFP101P50
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:43

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Dengue/Chikungunya/Zika Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595037577
Basic UDI-DI: 868511580PCR92JR
Reference: LYO92WS24
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:43

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Strep B qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595035139
Basic UDI-DI: 868511580PCR111G8
Reference: CFP111P100
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:43

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Malaria qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033821
Basic UDI-DI: 868499827PCR69YD
Reference: CFP69P50
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:43

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Candida auris qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033807
Basic UDI-DI: 868499827PCR68YB
Reference: CFP68P50
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:42

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HSV-1/HSV-2/VZV Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031995
Basic UDI-DI: 868511580PCR61JE
Reference: CFP61P25
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 07:42

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HHV8 ELITe MGB® Kit

HHV8 ELITe MGB® Kit

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

Manufacturer: ElitechGroup S.p.A.
Manufacturer SRN: IT-MF-000005919
UDI-DI: 08033891483968
Basic UDI-DI: 803389148HHV25CP
Reference: RTS038PLD
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:11

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HHV6 - ELITe Positive Control

HHV6 ELITe MGB® Kit

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

Manufacturer: ElitechGroup S.p.A.
Manufacturer SRN: IT-MF-000005919
UDI-DI: 08033891483517
Basic UDI-DI: 803389148HHV39D2
Reference: CTR036PLD
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:11

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AMPLIQUALITY HCV TYPE PLUS

AMPLIQUALITY HCV TYPE PLUS

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: AB ANALITICA srl
Manufacturer SRN: IT-MF-000032625
UDI-DI: 08033622784470
Basic UDI-DI: 803362278AINFrk00000000T5
Reference: 03-05-XX
EMDN: W0105020309
EMDN description: HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 24.09.2026 07:11

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DyonStrepA Strep A Rapid Test

Strep A Rapid Test

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

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 06976838234891
Basic UDI-DI: 697683823P201900F9
Reference: P2019C01
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Greece
Safety summary (SSCP/SSP): GS/TD-EU-P2019-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 24.09.2026 06:32

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

TOXOPLASMA WB IgG-IgM

-

IVD Class CNot specifiedOn the market

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: 37700277932748
Basic UDI-DI: 3770027793WBTOPGMWY
Reference: TOP-WB12GM
EMDN: W0105050199
EMDN description: TOXOPLASMA REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 24.09.2026 04:06

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LDBIO TOXO II IgM

LDBIO TOXO II IgM

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

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: 37700277932298
Basic UDI-DI: 3770027793WBT2M7T
Reference: T2M-12M
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 24.09.2026 04:06

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LDBIO TOXO II IgG

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

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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

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

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

Manufacturer products View details

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

Manufacturer products View details

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