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627 device results listed.

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06974671100113

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100113
Basic UDI-DI: B-06974671100113
Reference: DR-CM-A018
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:06

Manufacturer products Authorised representative products Authorised representative actors View details

PCT-Quantitative Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303001
Basic UDI-DI: B-06974566303001
Reference: CPC-402
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Test Kit (Homogeneous Chemiluminescence Immunoassay)

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Poclight Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000039609
UDI-DI: 06974524061530
Basic UDI-DI: B-06974524061530
Reference: HCLIA15102
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

PGⅡ Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521004295
Basic UDI-DI: B-06974521004295
Reference: SUPM078072
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

PGⅡ Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521004288
Basic UDI-DI: B-06974521004288
Reference: SUPM078036
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

PGⅠ Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521004271
Basic UDI-DI: B-06974521004271
Reference: SUPM079072
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

PGⅠ Assay kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521004264
Basic UDI-DI: B-06974521004264
Reference: SUPM079036
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

W0102069013

PCT Assay Kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001607
Basic UDI-DI: B-06974521001607
Reference: SUPM042072
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Assay Kit CLIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001591
Basic UDI-DI: B-06974521001591
Reference: SUPM042036
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Procalcitonin (PCT) (Time-resolved Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000709
Basic UDI-DI: B-06974521000709
Reference: SUPF007025
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:27

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

XJ004

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473308441
Basic UDI-DI: B-06974473308441
Reference: XJ004
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

G17 Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

WC002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473307598
Basic UDI-DI: B-06974473307598
Reference: WC002
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

PGI/PGII Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

WC001

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473300285
Basic UDI-DI: B-06974473300285
Reference: CW001
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Rapid Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 06974464591395
Basic UDI-DI: B-06974464591395
Reference: 5074C4X025
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details

06974323018377

Human Chorionic Gonadotropin (HCG) Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018377
Basic UDI-DI: B-06974323018377
Reference: IH009
EMDN: W0102069002
EMDN description: GONADOTROPIN-RELEASING HORMONE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details

06974323018360

Human Chorionic Gonadotropin (HCG) Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018360
Basic UDI-DI: B-06974323018360
Reference: IH009
EMDN: W0102069002
EMDN description: GONADOTROPIN-RELEASING HORMONE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details

06974323018353

Human Chorionic Gonadotropin (HCG) Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018353
Basic UDI-DI: B-06974323018353
Reference: IH009
EMDN: W0102069002
EMDN description: GONADOTROPIN-RELEASING HORMONE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details

06974323013723

PG I/PG II rapid test cassette (Rare earth nano fluorescence immunochromatography)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323013723
Basic UDI-DI: B-06974323013723
Reference: IF038
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

06974323013716

PG I/PG II rapid test cassette (Rare earth nano fluorescence immunochromatography)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323013716
Basic UDI-DI: B-06974323013716
Reference: IF038
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

06974323013709

PG I/PG II rapid test cassette (Rare earth nano fluorescence immunochromatography)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323013709
Basic UDI-DI: B-06974323013709
Reference: IF038
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details