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232 device results listed.

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Procalcitonin test (Up-converting Phosphor Technology)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403336
Basic UDI-DI: 697029753308LH
Reference: HGUPT04
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403138
Basic UDI-DI: 697029753054L9
Reference: HGCL08
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

PCT CLIA Microparticles

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547918
Basic UDI-DI: 697015090000043H2
Reference: CMR0205
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

PCT CLIA Microparticles

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547895
Basic UDI-DI: 697015090000043H2
Reference: CMR0203
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603581

PCT（CLIA）

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603581
Basic UDI-DI: 69268026MD71F00001VR
Reference: MCL02101E
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-PCT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715306
Basic UDI-DI: 692591270050GY
Reference: C86039-L
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S PCT sensitive KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632035
Basic UDI-DI: 426015763825BPCTsensKXXAD
Reference: 825050N
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S PCT-Q

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631779
Basic UDI-DI: 426015763106BPCT-Q000XXJJ
Reference: 106025N
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details

VIDAS® B•R•A•H•M•S PCT™

IVD Class CIVDR 2017/746Not intended for EU marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026557089
Basic UDI-DI: 357302BUDI000033SR
Reference: 30450-86
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 20:53

Manufacturer products View details

VIDAS® B•R•A•H•M•S PCT™

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026129392
Basic UDI-DI: 357302BUDI000011SF
Reference: 30450
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:50

Manufacturer products View details

Procalcitonin (PCT) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762759
Basic UDI-DI: 697134876027C27592N
Reference: MF-027-20
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764654
Basic UDI-DI: 697134876027C27592N
Reference: MF-027-25
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Diagnostic Kit (Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762339
Basic UDI-DI: B-06971348762339
Reference: MF-27-25
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Diagnostic Kit (Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760007
Basic UDI-DI: B-06971348760007
Reference: MF-27-20
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® BRAHMS PCT® II GEN

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771101301
Basic UDI-DI: 805677131804052
Reference: 318040
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

D-R1431428

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1431428
Basic UDI-DI: B-R1431428
Reference: R14314
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-R1431326

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1431326
Basic UDI-DI: B-R1431326
Reference: R14313
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-R1431224

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1431224
Basic UDI-DI: B-R1431224
Reference: R14312
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-R1431122

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R1431122
Basic UDI-DI: B-R1431122
Reference: R14311
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06975182500195
Basic UDI-DI: 697518250P1500168
Reference: P15001-25
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details