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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 18:27

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232 device results listed.

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PCT

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT01647H
Basic UDI-DI: B-DT01647H
Reference: DT0164
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

PCT

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT01637F
Basic UDI-DI: B-DT01637F
Reference: DT0163
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Unicorn-PCT

5 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT00737D
Basic UDI-DI: B-DT00737D
Reference: DT0073
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Unicorn-PCT

5 Tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT00727B
Basic UDI-DI: B-DT00727B
Reference: DT0072
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Unicorn-PCT

20 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT000974
Basic UDI-DI: B-DT000974
Reference: DT0009
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

Unicorn-PCT

20 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT000872
Basic UDI-DI: B-DT000872
Reference: DT0008
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

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-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

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

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

Procalcitonin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346106
Basic UDI-DI: B-20850076346106
Reference: CDPCT-401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-PCT

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912722991
Basic UDI-DI: 692591270050GY
Reference: C86317
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

PCT/IL-6 Rapid Test (FIA)

P232102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle useSterile

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600170
Basic UDI-DI: B-16972698600170
Reference: P232102
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

PCT Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763488
Basic UDI-DI: B-15065023763488
Reference: TV20010
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346109
Basic UDI-DI: B-10850076346109
Reference: CDPCT-401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 04:36

Manufacturer products Authorised representative products Authorised representative actors View details

FREND PCT

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540054
Basic UDI-DI: B-08809317540054
Reference: FRPC 025
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Cyprus
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ PCT Rapid Test Kit

VMD47

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030837
Basic UDI-DI: B-08684595030837
Reference: VMD47
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

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