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22.09.2026 04:18

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266 device results listed.

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ReLIA

Procalcitonin Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354101719
Basic UDI-DI: B-06971354101719
Reference: RG16371-50T
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

ReLIA

Procalcitonin Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354101702
Basic UDI-DI: B-06971354101702
Reference: RG16109-20T
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

ReLIA

Capillary Blood Procalcitonin Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354100200
Basic UDI-DI: B-06971354100200
Reference: RF16214-50T
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

ReLIA

Capillary Blood Procalcitonin Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354100194
Basic UDI-DI: B-06971354100194
Reference: RF16041-20T
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

ReLIA

Procalcitonin Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354100163
Basic UDI-DI: B-06971354100163
Reference: RF16190-50T
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

ReLIA

Procalcitonin Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354100156
Basic UDI-DI: B-06971354100156
Reference: RF16055-20T
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Slovenia
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go PCT Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936259
Basic UDI-DI: B-06971225936259
Reference: FIA07025
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo PCT Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225932459
Basic UDI-DI: B-06971225932459
Reference: KM05060
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin

Procalcitonin Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-06934175046294QT
Basic UDI-DI: B-06934175046294QT
Reference: 12600786
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-02B0022YK

Procalcitonin Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0022YK
Basic UDI-DI: B-02B0022YK
Reference: 2W001
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071510B2PY
Basic UDI-DI: B-0000128071510B2PY
Reference: HWTS-OT098
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

PCT STAT (eCLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062990
Basic UDI-DI: 69703416803205093JU
Reference: 0320510402
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

PCT STAT (eCLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063003
Basic UDI-DI: 69703416803205093JU
Reference: 0320510403
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

PCT STAT (eCLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063010
Basic UDI-DI: 69703416803205093JU
Reference: 0320510404
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ PCT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044469
Basic UDI-DI: 88061330BD09JB
Reference: CFPC-23-1
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS PCT Plus G

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044414
Basic UDI-DI: 880613300612C8
Reference: SMFP-112
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ PCT Plus G

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044377
Basic UDI-DI: 880613300128BW
Reference: CFPC-136
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Lithuania
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465232950
Basic UDI-DI: 697846523ProteinB03RC
Reference: 2×100 test
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) test kit (fluorescence immunochromatography)

3Q-FA1000

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Sanqi Biomedical(Shandong)Co.,Ltd.
Manufacturer SRN: CN-MF-000030641
UDI-DI: 06974472730342
Basic UDI-DI: 697447273034MQ
Reference: 4973
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) test kit (fluorescence immunochromatography)

3Q-FA1000

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Sanqi Biomedical(Shandong)Co.,Ltd.
Manufacturer SRN: CN-MF-000030641
UDI-DI: 06974472730335
Basic UDI-DI: 697447273033MN
Reference: 4973
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details