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907 device results listed.

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Streptococcus pneumoniae Ag Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD105X8
Basic UDI-DI: B-GKPD105X8
Reference: GKPD105
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCSYP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSYP-402aHGN7
Basic UDI-DI: B-GCSYP-402aHGN7
Reference: GCSYP-402a
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Rapid Test Strip (Whole Blood/Serum/Plasma)

GCSYP-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSYP-401aHGMY
Basic UDI-DI: B-GCSYP-401aHGMY
Reference: GCSYP-401a
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Rapid Test Strip (Whole Blood/Serum/Plasma)

GCSYP-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSYP-401aGC
Basic UDI-DI: B-GCSYP-401aGC
Reference: GCSYP-401a
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Rapid Test Cassette (Serum/Plasma)

GCSYP-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSYP-302aHGMS
Basic UDI-DI: B-GCSYP-302aHGMS
Reference: GCSYP-302a
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Rapid Test Cassette (Serum/Plasma)

GCSYP-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSYP-302aG8
Basic UDI-DI: B-GCSYP-302aG8
Reference: GCSYP-302a
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Rapid Test Strip (Serum/Plasma)

GCSYP-301a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSYP-301aHGMK
Basic UDI-DI: B-GCSYP-301aHGMK
Reference: GCSYP-301a
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Rapid Test Strip (Serum/Plasma)

GCSYP-301a

IVD generalIVDDOn the marketAnimal tissuesKitSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSYP-301aG5
Basic UDI-DI: B-GCSYP-301aG5
Reference: GCSYP-301a
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette (Throat Swab)

GCSTR-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSTR-502aHGL7
Basic UDI-DI: B-GCSTR-502aHGL7
Reference: GCSTR-502a
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette (Throat Swab)

GCSTR-502Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSTR-502CaHGUH
Basic UDI-DI: B-GCSTR-502CaHGUH
Reference: GCSTR-502Ca
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette (Throat Swab)

GCSTR-502Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-502CaD3
Basic UDI-DI: B-GCSTR-502CaD3
Reference: GCSTR-502Ca
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette (Throat Swab)

GCSTR-502CSa

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-502CSaJM
Basic UDI-DI: B-GCSTR-502CSaJM
Reference: GCSTR-502CSa
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette (Throat Swab)

GCSTR-502CSa

IVD generalIVDDOn the marketAnimal tissuesKitSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSTR-502CSaHGAA
Basic UDI-DI: B-GCSTR-502CSaHGAA
Reference: GCSTR-502CSa
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Strip (Throat Swab)

GCSTR-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSTR-501aHGKY
Basic UDI-DI: B-GCSTR-501aHGKY
Reference: GCSTR-501a
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Strip (Throat Swab)

GCSTR-501Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSTR-501CaHGU6
Basic UDI-DI: B-GCSTR-501CaHGU6
Reference: GCSTR-501Ca
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Strip (Throat Swab)

GCSTR-501Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-501CaCW
Basic UDI-DI: B-GCSTR-501CaCW
Reference: GCSTR-501Ca
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Strip (Throat Swab)

GCSTR-501CSa

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-501CSaJE
Basic UDI-DI: B-GCSTR-501CSaJE
Reference: GCSTR-501CSa
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Strip (Throat Swab)

GCSTR-501CSa

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSTR-501CSaHG9V
Basic UDI-DI: B-GCSTR-501CSaHG9V
Reference: GCSTR-501CSa
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Ag Rapid Test Device (Feces)

GCHP-606a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHP-606aHGQD
Basic UDI-DI: B-GCHP-606aHGQD
Reference: GCHP-606a
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ag Rapid Test Cassette (Feces)

GCHP-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHP-602aHGPH
Basic UDI-DI: B-GCHP-602aHGPH
Reference: GCHP-602a
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details