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669 device results listed.

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Procalcitonin Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDPCT-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-402a5B
Basic UDI-DI: B-GDPCT-402a5B
Reference: GDPCT-402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDMYO-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDMYO-402aD7
Basic UDI-DI: B-GDMYO-402aD7
Reference: GDMYO-402a
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Rapid Test Cassette (Whole Blood/Plasma)

GDDDI-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDDDI-402bS8
Basic UDI-DI: B-GDDDI-402bS8
Reference: GDDDI-402b
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDCRP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDCRP-402a3X
Basic UDI-DI: B-GDCRP-402a3X
Reference: GDCRP-402a
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDCKM-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDCKM-402aWW
Basic UDI-DI: B-GDCKM-402aWW
Reference: GDCKM-402a
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

One Step CK-MB Test Cassette (Serum/Plasma)

GDCKM-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDCKM-302aWP
Basic UDI-DI: B-GDCKM-302aWP
Reference: GDCKM-302a
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDCAR-W435a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDCAR-W435a2C
Basic UDI-DI: B-GDCAR-W435a2C
Reference: GDCAR-W435a
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Test Cassette (Serum/Plasma)

GDCAR-335a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDCAR-335aU6
Basic UDI-DI: B-GDCAR-335aU6
Reference: Myoglobin/CK-MB/Troponin I Combo Test Cassette (Serum/Plasma)
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma)

GCZIK(NS1)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCZIK(NS1)-402aCD
Basic UDI-DI: B-GCZIK(NS1)-402aCD
Reference: GCZIK(NS1)-402a
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCZIK(IgG/IgM)-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCZIK(IgG/IgM)-T402a3U
Basic UDI-DI: B-GCZIK(IgG/IgM)-T402a3U
Reference: GCZIK(IgG/IgM)-T402a
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCZIK(IgG)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCZIK(IgG)-402bUW
Basic UDI-DI: B-GCZIK(IgG)-402bUW
Reference: GCZIK(IgG)-402b
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

V. cholerae O1 Ag Rapid Test Cassette (Feces)

GCVCH(O1)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCVCH(O1)-602a7J
Basic UDI-DI: B-GCVCH(O1)-602a7J
Reference: GCVCH(O1)-602a
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

V. cholerae O1/O139 Ag Combo Rapid Test Cassette (Feces)

GCVCH(O1/O9)-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCVCH(O1/O9)-602aK7
Basic UDI-DI: B-GCVCH(O1/O9)-602aK7
Reference: GCVCH(O1/O9)-602a
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Typhoid IgG/IgM Rapid Test Cassette (Serum/Plasma)

GCTYP-302b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTYP-302bGV
Basic UDI-DI: B-GCTYP-302bGV
Reference: GCTYP-302b
EMDN: W0105011001
EMDN description: SALMONELLA ANTIGEN DETECTION
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

Typhoid IgG/IgM Rapid Test Cassette(Serum/Plasma)

GCTYP-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTYP-302aGT
Basic UDI-DI: B-GCTYP-302aGT
Reference: GCTYP-302a
EMDN: W0105011001
EMDN description: SALMONELLA ANTIGEN DETECTION
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

Trichomonas Ag Rapid Test Cassette (Swab)

GCTV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTV-502a9Z
Basic UDI-DI: B-GCTV-502a9Z
Reference: GCTV-502a
EMDN: W0105050210
EMDN description: TRICHOMONAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Toxoplasma gondii (Toxo) IgM Rapid Test

GCTOX(IgM)-302a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTOX(IgM)-302aBR
Basic UDI-DI: B-GCTOX(IgM)-302aBR
Reference: GCTOX(IgM)-302a
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
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

Toxoplasma gondii (Toxo) IgG/IgM Rapid Test

GCTOX(IgG/IgM)-302a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTOX(IgG/IgM)-302a4G
Basic UDI-DI: B-GCTOX(IgG/IgM)-302a4G
Reference: GCTOX(IgG/IgM)-302a
EMDN: W0105050101
EMDN description: TOXOPLASMA ANTIBODY (TOTAL)
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

Toxoplasma gondii (Toxo) IgG Rapid Test

GCTOX(IgG)-302a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTOX(IgG)-302a8K
Basic UDI-DI: B-GCTOX(IgG)-302a8K
Reference: GCTOX(IgG)-302a
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
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

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

GCTB-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTB-402aZK
Basic UDI-DI: B-GCTB-402aZK
Reference: GCTB-402a
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details