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586 device results listed.

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Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870057
Basic UDI-DI: B-06974081870057
Reference: PCR001
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Test Kit (Colloidal Gold) (Cassette)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870040
Basic UDI-DI: B-06974081870040
Reference: NCAG
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx SARS-CoV-2 qPCR Kit v2.3

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717219
Basic UDI-DI: B-08683079717219
Reference: IP202103-500
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

RevoDx SARS-CoV-2 qPCR Kit v2.3

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717202
Basic UDI-DI: B-08683079717202
Reference: IP202103-100
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

RevoDx SARS-CoV-2 qPCR Kit v2.2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717196
Basic UDI-DI: B-08683079717196
Reference: IP202008-500
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

RevoDx SARS-CoV-2 qPCR Kit v2.2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717189
Basic UDI-DI: B-08683079717189
Reference: IP202008-100
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

SARS-CoV-2 (COVID-19) Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 07350123504705
Basic UDI-DI: B-07350123504705
Reference: ICOV-803H
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277517980
Basic UDI-DI: B-06970277517980
Reference: ICOV-802H
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

06955792734494

SARS Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792734494
Basic UDI-DI: B-06955792734494
Reference: S3173E-48
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732674

SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)

IVD self-testing devicesIVDDNo longer on the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732674
Basic UDI-DI: B-06955792732674
Reference: S3120E-25-H
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732667

SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)

IVD self-testing devicesIVDDNo longer on the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732667
Basic UDI-DI: B-06955792732667
Reference: S3120E-10-H
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732650

SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)

IVD self-testing devicesIVDDNo longer on the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732650
Basic UDI-DI: B-06955792732650
Reference: S3120E-5-H
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732643

SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)

IVD self-testing devicesIVDDNo longer on the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732643
Basic UDI-DI: B-06955792732643
Reference: S3120E-1-H
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732254

Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732254
Basic UDI-DI: B-06955792732254
Reference: S3174E-48
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR SARS-CoV-2 Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570169
Basic UDI-DI: B-04719878570169
Reference: PCRAE0114
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR SARS-CoV-2 Gen 2 Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570220
Basic UDI-DI: B-04719878570220
Reference: PCRAE0120
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

04560189216426

CL AIA-PACK SARS-CoV-2-Ag CONTROL SET

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189216426
Basic UDI-DI: B-04560189216426
Reference: 0029374
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

04560189216419

CL AIA-PACK SARS-CoV-2-Ag SAMPLE TREATMENT SOLUTION

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189216419
Basic UDI-DI: B-04560189216419
Reference: 0029574
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 R-GENE®

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026624576
Basic UDI-DI: 357302BUDI000911TU
Reference: 424017
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

COVID-19 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INCP-R502AN
Basic UDI-DI: B-INCP-R502AN
Reference: INCP-R502
EMDN: W0105041101
EMDN description: CORONAVIRUS AG
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details