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727 device results listed.

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COVID-19/Flu A&B/RSV/Adeno Ag Control Kit

GCFCRA-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRA-PN27N
Basic UDI-DI: B-GCFCRA-PN27N
Reference: GCFCRA-PN2
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab)

GCFCRA-545a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRA-545aWP
Basic UDI-DI: B-GCFCRA-545aWP
Reference: GCFCRA-545a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

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COVID-19/Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab)

GCFCR-T525a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCR-T525a3T
Basic UDI-DI: B-GCFCR-T525a3T
Reference: GCFCR-T525a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

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COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab)

GCFCR-T525a-NN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCR-T525a-NNNG
Basic UDI-DI: B-GCFCR-T525a-NNNG
Reference: GCFCR-T525a-NN
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

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COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab)

GCFCR-T525Sa-DD

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCR-T525Sa-DD4H
Basic UDI-DI: B-GCFCR-T525Sa-DD4H
Reference: GCFCR-T525Sa-DD
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Smart Rapid COVID-19 & Flu A/B Ag Test Device

GCFC-T503a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFC-T503aUH
Basic UDI-DI: B-GCFC-T503aUH
Reference: GCFC-T503a
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

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COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)

GCFC-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFC-T502aUE
Basic UDI-DI: B-GCFC-T502aUE
Reference: GCFC-T502a
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

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EV71 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCEV71(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCEV71(IgM)-402a5W
Basic UDI-DI: B-GCEV71(IgM)-402a5W
Reference: GCEV71(IgM)-402a
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 & Influenza A/B Rapid Test Cassette (Swab)

GCFC-525Sa

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFC-525SaM8
Basic UDI-DI: B-GCFC-525SaM8
Reference: GCFC-525Sa
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

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EV71 IgM Rapid Test Cassette (Serum/Plasma)

GCEV71(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCEV71(IgM)-302a5P
Basic UDI-DI: B-GCEV71(IgM)-302a5P
Reference: GCEV71(IgM)-302a
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCDEN-425a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCDEN-425aUL
Basic UDI-DI: B-GCDEN-425aUL
Reference: GCDEN-425a
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:25

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

GCDEN(ab)-402e

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCDEN(ab)-402eQG
Basic UDI-DI: B-GCDEN(ab)-402eQG
Reference: GCDEN(ab)-402e
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCDEN(ab)-402c

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCDEN(ab)-402cQC
Basic UDI-DI: B-GCDEN(ab)-402cQC
Reference: GCDEN(ab)-402c
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Ag Rapid Test Cassette(Whole Blood/Serum/Plasma)

GCDEN(NS)-402d

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCDEN(NS)-402dAS
Basic UDI-DI: B-GCDEN(NS)-402dAS
Reference: GCDEN(NS)-402d
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCDEN(NS)-402c

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCDEN(NS)-402cAQ
Basic UDI-DI: B-GCDEN(NS)-402cAQ
Reference: GCDEN(NS)-402c
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)

GCCr(Ag)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCr(Ag)-402aRU
Basic UDI-DI: B-GCCr(Ag)-402aRU
Reference: GCCr(Ag)-402a
EMDN: W0105060303
EMDN description: CRYPTOCOCCUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

CARBA 5 In 1 Rapid Test Cassette

GCCRE-T1402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCRE-T1402a25
Basic UDI-DI: B-GCCRE-T1402a25
Reference: GCCRE-T1402a
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM CONTROL Kit

GCCOV-PN10，GCCOV-PN20

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-PNN4
Basic UDI-DI: B-GCCOV-PNN4
Reference: GCCOV-PN10，GCCOV-PN20
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Digital COVID-19 Ag Rapid Test (Swab)

GCCOV-D503a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-D503a4W
Basic UDI-DI: B-GCCOV-D503a4W
Reference: GCCOV-D503a
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 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Ag Rapid Test Cassette (Oral Fluid)

GCCOV-702a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-702a4Q
Basic UDI-DI: B-GCCOV-702a4Q
Reference: GCCOV-702a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details