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146 device results listed.

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PARAINFLUENZA 3 ELISA IgG/IgM

G/M1011

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320389
Basic UDI-DI: B-08436040320389
Reference: G/M1011
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

PARAINFLUENZA 2 ELISA IgG/IgM

G/M1010

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320372
Basic UDI-DI: B-08436040320372
Reference: G/M1010
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

PARAINFLUENZA 1 ELISA IgG/IgM

G/M1009

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320365
Basic UDI-DI: B-08436040320365
Reference: G/M1009
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

INFLUENZA B ELISA IgG/IgM

G/M1008

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320266
Basic UDI-DI: B-08436040320266
Reference: G/M1008
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

INFLUENZA A ELISA IgG/IgM

G/M1007

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040320259
Basic UDI-DI: B-08436040320259
Reference: G/M1007
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:17

Manufacturer products View details

06955792733541

SARS-CoV-2 S-RBD Antibodies Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733541
Basic UDI-DI: B-06955792733541
Reference: S3132E-25
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

06955792733534

SARS-CoV-2 Neutralizing Antibodies Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733534
Basic UDI-DI: B-06955792733534
Reference: S3131E-25
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

06930317895393

48 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317895393
Basic UDI-DI: B-06930317895393
Reference: DNK-1901-56
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

06930317883345

24 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317883345
Basic UDI-DI: B-06930317883345
Reference: DNK-1901-56
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

06930317870048

48 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317870048
Basic UDI-DI: B-06930317870048
Reference: DNK-1901-55
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

06930317807747

24 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317807747
Basic UDI-DI: B-06930317807747
Reference: DNK-1901-55
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802780

200 tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802780
Basic UDI-DI: B-06930317802780
Reference: DNK-1901-52
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802773

100 tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802773
Basic UDI-DI: B-06930317802773
Reference: DNK-1901-52
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802766

200 tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802766
Basic UDI-DI: B-06930317802766
Reference: DNK-1901-51
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802759

100 tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802759
Basic UDI-DI: B-06930317802759
Reference: DNK-1901-51
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802605

200 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802605
Basic UDI-DI: B-06930317802605
Reference: DNK-1901-43
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802599

100 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802599
Basic UDI-DI: B-06930317802599
Reference: DNK-1901-43
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802582

200 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802582
Basic UDI-DI: B-06930317802582
Reference: DNK-1901-42
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802575

100 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802575
Basic UDI-DI: B-06930317802575
Reference: DNK-1901-42
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Antigen Rapid Tests for Self-Testing

CG3610

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807602942
Basic UDI-DI: B-06921807602942
Reference: CG3625
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details