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08885019710803

300142

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710803
Basic UDI-DI: B-08885019710803
Reference: 300142
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ SARS-CoV-2 fast PCR Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103456
Basic UDI-DI: B-08809240103456
Reference: RV10345Z
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ SARS-CoV-2 fast PCR Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103449
Basic UDI-DI: B-08809240103449
Reference: RV10344X
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ SARS-CoV-2 Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102480
Basic UDI-DI: B-08809240102480
Reference: RV10248X
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ SARS-CoV-2 Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102473
Basic UDI-DI: B-08809240102473
Reference: RV10247Y
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ 2019-nCoV Assay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102435
Basic UDI-DI: B-08809240102435
Reference: RP10243X
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ 2019-nCoV Assay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102442
Basic UDI-DI: B-08809240102442
Reference: RP10244Y
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

PaxView® SARS-CoV-2 real-time RT-PCR Kit

R0502

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: PaxGenBio Co., Ltd.
Manufacturer SRN: KR-MF-000024696
UDI-DI: 08800097500023
Basic UDI-DI: B-08800097500023
Reference: R0502
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details

PowerChek™ SARS-CoV-2 Advanced Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056369104
Basic UDI-DI: B-08800056369104
Reference: IR6906
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

PowerChek™ SARS-CoV-2 Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056369029
Basic UDI-DI: B-08800056369029
Reference: IR6902
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

PowerChek™ Coronavirus 229E / OC43 / NL63 / HKU1 Real-time PCR Kit Ver.1.0

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056364031
Basic UDI-DI: B-08800056364031
Reference: R6410TA
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima SARS-CoV-2 Assay

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517004
Basic UDI-DI: 54200455DIAGAPTSARSCOV2CC
Reference: PRD-07881
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 09.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima SARS-CoV-2 Assay Controls Kit

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045517035
Basic UDI-DI: 54200455DIAGAPTSARSCOV2CC
Reference: PRD-07882
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 09.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

08800026300700

Exdia COVID-19 Ag

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Precision Biosensor Inc.
Manufacturer SRN: KR-MF-000034861
UDI-DI: 08800026300700
Basic UDI-DI: B-08800026300700
Reference: PR-FC13, PR-FC13N
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 09.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens SARS-CoV-2 qPCR Kit

LYO106WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275903
Basic UDI-DI: B-08684998275903
Reference: LYO106
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:21

Manufacturer products View details

RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212762
Basic UDI-DI: B-08684387212762
Reference: IP202339-100
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212755
Basic UDI-DI: B-08684387212755
Reference: IP202339-25
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387210171
Basic UDI-DI: B-08684387210171
Reference: IP202221-480
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 01:46

Manufacturer products View details

RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387210058
Basic UDI-DI: B-08684387210058
Reference: IP202221-384
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 01:46

Manufacturer products View details

RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387210041
Basic UDI-DI: B-08684387210041
Reference: IP202221-96
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 01:46

Manufacturer products View details