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620 device results listed.

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Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H15

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H15GQ
Basic UDI-DI: B-GCCOV-502a-H15GQ
Reference: GCCOV-502a-H15
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H10

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H10GE
Basic UDI-DI: B-GCCOV-502a-H10GE
Reference: GCCOV-502a-H10
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Test Strip

GCCOV-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-501aHG49
Basic UDI-DI: B-GCCOV-501aHG49
Reference: GCCOV-501a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:24

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COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCCOV-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-402aHG43
Basic UDI-DI: B-GCCOV-402aHG43
Reference: GCCOV-402a
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

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COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCCOV-402Ba

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-402BaHGAL
Basic UDI-DI: B-GCCOV-402BaHGAL
Reference: GCCOV-402Ba
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCCOV(NAb)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV(NAb)-402bHGN8
Basic UDI-DI: B-GCCOV(NAb)-402bHGN8
Reference: GCCOV(NAb)-402b
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)

GCCOV(Del)-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV(Del)-T502aHGQG
Basic UDI-DI: B-GCCOV(Del)-T502aHGQG
Reference: GCCOV(Del)-T502a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab)

GCCOV(B117)-525a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV(B117)-525aHGE5
Basic UDI-DI: B-GCCOV(B117)-525aHGE5
Reference: GCCOV(B117)-525a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Control Kit

GCCOV(Ag)-PN20

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV(Ag)-PN20HG4Y
Basic UDI-DI: B-GCCOV(Ag)-PN20HG4Y
Reference: GCCOV(Ag)-PN20
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Control Kit

GCCOV(Ag)-PN10

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV(Ag)-PN10HG4R
Basic UDI-DI: B-GCCOV(Ag)-PN10HG4R
Reference: GCCOV(Ag)-PN10
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Chikungunya Ag Test Cassette (Whole Blood/Serum/Plasma)

GCCHK-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCHK-402aHGQE
Basic UDI-DI: B-GCCHK-402aHGQE
Reference: GCCHK-402a
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCCHK(IgM/IgG)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCHK(IgM/IgG)-402aHGMJ
Basic UDI-DI: B-GCCHK(IgM/IgG)-402aHGMJ
Reference: GCCHK(IgM/IgG)-402a
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCCHK(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCHK(IgM)-402aHGC5
Basic UDI-DI: B-GCCHK(IgM)-402aHGC5
Reference: GCCHK(IgM)-402a
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgM Rapid Test Cassette (Serum/Plasma)

GCCHK(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCHK(IgM)-302aHGBQ
Basic UDI-DI: B-GCCHK(IgM)-302aHGBQ
Reference: GCCHK(IgM)-302a
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)

GCCHK(IgG/IgM)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCHK(IgG/IgM)-402bHGJB
Basic UDI-DI: B-GCCHK(IgG/IgM)-402bHGJB
Reference: GCCHK(IgG/IgM)-402b
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCCHA-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCHA-402aHGJG
Basic UDI-DI: B-GCCHA-402aHGJG
Reference: GCCHA-402a
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas Ab Rapid Test Cassette (Serum/Plasma)

GCCHA-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCHA-302aHGJ3
Basic UDI-DI: B-GCCHA-302aHGJ3
Reference: GCCHA-302a
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces)

GCCD-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCD-602aHGCS
Basic UDI-DI: B-GCCD-602aHGCS
Reference: GCCD-602a
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile Toxin A&B Rapid Test Cassette (Feces)

GCCD(Toxin A/B)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCD(ToxinA/B)-602aHG5N
Basic UDI-DI: B-GCCD(ToxinA/B)-602aHG5N
Reference: GCCD(Toxin A/B)-602a
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile Antigen GDH Rapid Test Cassette (Feces)

GCCD(GDH)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCD(GDH)-602aHG2C
Basic UDI-DI: B-GCCD(GDH)-602aHG2C
Reference: GCCD(GDH)-602a
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details