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701 device results listed.

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iStar-PCT Ⅱ

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76144FL
Basic UDI-DI: B-DC76144FL
Reference: DC76144
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-PCT Ⅱ

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76143FJ
Basic UDI-DI: B-DC76143FJ
Reference: DC76142
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-PCT Ⅱ

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76142FG
Basic UDI-DI: B-DC76142FG
Reference: DC76142
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-PCT Ⅱ

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76141FE
Basic UDI-DI: B-DC76141FE
Reference: DC76141
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:06

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Pepsinogen II

30 Tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76060FD
Basic UDI-DI: B-DC76060FD
Reference: DC76060
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Pepsinogen I

30 Tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76059FU
Basic UDI-DI: B-DC76059FU
Reference: DC76059
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Pepsinogen II

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76026FD
Basic UDI-DI: B-DC76026FD
Reference: DC76026
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Pepsinogen I

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76025FB
Basic UDI-DI: B-DC76025FB
Reference: DC76025
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-PCT

30 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76014F6
Basic UDI-DI: B-DC76014F6
Reference: DC76014
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

D-CN-MF-000013251RC

PG I Reagent Kit

IVD generalIVDDNo longer on the marketKitProfessional testingReagent

Manufacturer: Virtue Diagnostics (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000013251
UDI-DI: D-CN-MF-000013251RC
Basic UDI-DI: B-CN-MF-000013251RC
Reference: 12001008,12001048
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: -
Authorised representative: Kingsmead Service B.V.
Last updated: 13.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-AL-1572Y

AL-157 Gucagon ELISA (CE)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ansh Labs
Manufacturer SRN: US-MF-000054510
UDI-DI: D-AL-1572Y
Basic UDI-DI: B-AL-1572Y
Reference: AL-157
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: QNET B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

PMN-Elastase

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313276158
Basic UDI-DI: B-86060313276158
Reference: C1817ELA
EMDN: W0102069009
EMDN description: ELASTASE (PANCREATIC POLYPEPTIDE)
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

Pancreatic elastase

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313274628
Basic UDI-DI: B-86060313274628
Reference: C1825PELA
EMDN: W0102069009
EMDN description: ELASTASE (PANCREATIC POLYPEPTIDE)
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7M17FD
Basic UDI-DI: B-7M17FD
Reference: 7M17V1-B-EU, 7M17U1-B-EU, 7M17P1-B-EU
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Gastrin-17 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C18DV
Basic UDI-DI: B-7C18DV
Reference: 7C18V1-B-EU, 7C18U1-B-EU, 7C18P1-B-EU
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen II assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C17DT
Basic UDI-DI: B-7C17DT
Reference: 7C17V1-B-EU, 7C17U1-B-EU, 7C17P1-B-EU
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen I assay (CLIA)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C16DR
Basic UDI-DI: B-7C16DR
Reference: 7C16V1-B-EU, 7C16U1-B-EU, 7C16P1-B-EU
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-35276

Pepsinogen II Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-35276
Basic UDI-DI: B-35276
Reference: /
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-35174

Pepsinogen I Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-35174
Basic UDI-DI: B-35174
Reference: /
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-3326Y

Procalcitonin Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3326Y
Basic UDI-DI: B-3326Y
Reference: /
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details