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Novel Coronavirus(COVID-19) Neutralizing Antibody Rapid Test Device(whole blood/serum/plasma)

A040501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753474907
Basic UDI-DI: B-06976753474907
Reference: A040501D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)

A361301D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753474877
Basic UDI-DI: B-06976753474877
Reference: A361301D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

AdenovirusRotavirus Combo Rapid Test Device(Feces)

A330401D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753474754
Basic UDI-DI: B-06976753474754
Reference: A330401D
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Rapid Test Device(Feces)

A320401D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753474723
Basic UDI-DI: B-06976753474723
Reference: A320401D
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Rapid Test Device (whole blood/serum/plasma)

A260501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473436
Basic UDI-DI: B-06976753473436
Reference: A260501D
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgGIgM Rapid Test Device (whole blood/serum/plasma)

A250501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473405
Basic UDI-DI: B-06976753473405
Reference: A250501D
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgGIgM and NS1 Rapid Test Device (whole blood/serum/plasma)

A240501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473375
Basic UDI-DI: B-06976753473375
Reference: A240501D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test Device(whole blood/serum/plasma)

J010501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473344
Basic UDI-DI: B-06976753473344
Reference: J010501D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva)

A220201D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473283
Basic UDI-DI: B-06976753473283
Reference: A220201D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (swab)

A211301D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473252
Basic UDI-DI: B-06976753473252
Reference: A211301D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-Cov-2＆Influenza A＆B Combo Rapid Test Cassette (swab)

A231301D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473313
Basic UDI-DI: B-06976753473313
Reference: A231301D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Rapid Test (Throat swab)

A200101T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473221
Basic UDI-DI: B-06976753473221
Reference: A200101T
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCOV IgGIgM Rapid Test Device (whole blood/serum/plasma)

A190501D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473191
Basic UDI-DI: B-06976753473191
Reference: A190501D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

2-IN-1 COVID-19 Antigen Rapid Test Device (swab)

A181301D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753473160
Basic UDI-DI: B-06976753473160
Reference: A181301D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

2-IN-1 COVID-19 Antigen Rapid Test Device (Nasal&Saliva)

A151601D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753472989
Basic UDI-DI: B-06976753472989
Reference: A151601D
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 00:58

Manufacturer products Authorised representative products Authorised representative actors View details

Zika NS1 Rapid Test

GIZNS1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763392
Basic UDI-DI: B-06976202763392
Reference: GIZNS1-402
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG/IgM Rapid Test

GIZGM

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763385
Basic UDI-DI: B-06976202763385
Reference: GIZGM-422
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG/IgM/NS1 Combo Rapid Test

GIZGMN

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763378
Basic UDI-DI: B-06976202763378
Reference: GIZGMN-432
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

Enterovirus Rapid Test

GIHEV

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763347
Basic UDI-DI: B-06976202763347
Reference: GIHEV-422
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

EV71 IgM Rapid Test

GIEV71

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763033
Basic UDI-DI: B-06976202763033
Reference: GIEV71-402
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details