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LyoSens™

Lyme Disease qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259073
Basic UDI-DI: 868511580PCR67JS
Reference: LYO67WS24
EMDN: W0105010605
EMDN description: LYME DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:23

Manufacturer products View details

LyoSens™

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: 08683548259035
Basic UDI-DI: 868511580PCR61JE
Reference: LYO61WS24
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 01:23

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SARS-CoV-2 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-COVID-502bA5
Basic UDI-DI: B-COVID-502bA5
Reference: COVID-502b
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Spain
Authorised representative: Llins Service & Consulting GmbH
Last updated: 24.09.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

recomBlot, recomLine Substrate TMB prec.

Dyeing solutions

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125640
Basic UDI-DI: 42505711B2102WJ
Reference: 10068
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 23:52

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recomLine, recomBlot Anti-human IgG conjugate

Conjugates

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125596
Basic UDI-DI: 42505711B2101WG
Reference: 10064
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 23:16

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recomBlot, recomLine Wash buffer A 10x

Buffer solutions

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125541
Basic UDI-DI: 42505711B2100WE
Reference: 10061
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 23:16

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RightSign

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

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: 06934078031939
Basic UDI-DI: 69340780CHL71A00JT
Reference: WCHL-C71P002
EMDN: W0105090101
EMDN description: CHLAMYDIA AG - RT & POC
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.09.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

recomLine Avidity reagent

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125817
Basic UDI-DI: 42505711B2100WE
Reference: 11060
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

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recomLine Skim Milk Powder

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125800
Basic UDI-DI: 42505711B2100WE
Reference: 13061
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

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recomWell Substrate TMB fast2

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125794
Basic UDI-DI: 42505711B2102WJ
Reference: 12067
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

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recomWell Stop solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125787
Basic UDI-DI: 42505711B2102WJ
Reference: 12064
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

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recomWell Dilution buffer

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125770
Basic UDI-DI: 42505711B2100WE
Reference: 12062
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomWell Wash buffer 10x

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125763
Basic UDI-DI: 42505711B2100WE
Reference: 12061
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomBead Anti-human IgA conjugate

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125756
Basic UDI-DI: 42505711B2101WG
Reference: 11066
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomBead Anti-human IgM conjugate

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125749
Basic UDI-DI: 42505711B2101WG
Reference: 11065
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomBead Anti-human IgG conjugate

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125732
Basic UDI-DI: 42505711B2101WG
Reference: 11064
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomBead Wash- and Dilution buffer 6x

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125725
Basic UDI-DI: 42505711B2100WE
Reference: 12060
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomBlot, recomLine Substrate TMB prec.

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125657
Basic UDI-DI: 42505711B2102WJ
Reference: 10078
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomLine Anti-human IgA conjugate

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125633
Basic UDI-DI: 42505711B2101WG
Reference: 10066
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomLine Anti-human IgM conjugate

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125626
Basic UDI-DI: 42505711B2101WG
Reference: 10065
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details