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139 device results listed.

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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

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

GeneProof SARS-CoV-2 Advanced PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300760
Basic UDI-DI: B-08595696300760
Reference: COV2A/GP/100
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:57

Manufacturer products View details

GeneProof SARS-CoV-2 Screening MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300104
Basic UDI-DI: B-08595696300104
Reference: COV2S/MC/190
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:57

Manufacturer products View details

GeneProof SARS-CoV-2 Advanced PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300746
Basic UDI-DI: B-08595696300746
Reference: COV2A/GP/025
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:57

Manufacturer products View details

GeneProof SARS-CoV-2 Screening MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300081
Basic UDI-DI: B-08595696300081
Reference: COV2S/MC/038
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:57

Manufacturer products View details

06977883370008

ULSEN ®SARS-CoV-2 Whole Genome Capture Kit Instruction

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beijing Microfuture Technology Limited
Manufacturer SRN: CN-MF-000048064
UDI-DI: 06977883370008
Basic UDI-DI: B-06977883370008
Reference: ULSEN ®SARS-CoV-2 Whole Genome Capture Kit Instruction
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

06975447582058

12 reaction/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447582058
Basic UDI-DI: B-06975447582058
Reference: 106-0050-01
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Pluslife SARS-CoV-2 Card

SARS-CoV-2 Nucleic Acid Testing Card

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120028
Basic UDI-DI: B-06975327120028
Reference: RM1010202-10
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details