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639 device results listed.

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Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma)

GECEA-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GECEA-401aPG
Basic UDI-DI: B-GECEA-401aPG
Reference: GECEA-401a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Tumor Antigen Rapid Test Cassette (Urine)

GEBTA-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEBTA-102aWA
Basic UDI-DI: B-GEBTA-102aWA
Reference: GEBTA-102a
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein Rapid Test Cassette(Whole Blood/Serum/Plasma)

GEAFP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEAFP-402aUZ
Basic UDI-DI: B-GEAFP-402aUZ
Reference: GEAFP-402a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein Rapid Test Strip (Whole Blood/Serum/Plasma)

GEAFP-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEAFP-401aUW
Basic UDI-DI: B-GEAFP-401aUW
Reference: GEAFP-401a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402d

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDTRO-402dDT
Basic UDI-DI: B-GDTRO-402dDT
Reference: GDTRO-402d
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402b

IVD generalIVDDOn the marketInstrumentKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDTRO-402bDP
Basic UDI-DI: B-GDTRO-402bDP
Reference: GDTRO-402b
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 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDTRO-402aDM
Basic UDI-DI: B-GDTRO-402aDM
Reference: GDTRO-402a
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 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Serum/Plasma)

GDTRO-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDTRO-302aDE
Basic UDI-DI: B-GDTRO-302aDE
Reference: GDTRO-302a
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 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDPCT-T402a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-T402aC6
Basic UDI-DI: B-GDPCT-T402aC6
Reference: GDPCT-T402a
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

Procalcitonin Semi-Quantitative Rapid Test Strip (Whole Blood/Serum/Plasma)

GDPCT-T401a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-T401aC3
Basic UDI-DI: B-GDPCT-T401aC3
Reference: GDPCT-T401a
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

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