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266 device results listed.

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HOKAPI™ B·R·A·H·M·S PCT

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390435281
Basic UDI-DI: 69713904310047H
Reference: 011004101
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:01

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin(PCT) Assay Kit(Chemiluminescence)

2×50 test/box Calibrator:0.5mL×6

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522644652
Basic UDI-DI: B-06970522644652
Reference: DC0209
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 04:46

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Assay Kits (Lateral Flow Immunoassay)

25 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341681517
Basic UDI-DI: B-06970341681517
Reference: 745001
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603598

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603598
Basic UDI-DI: 69268026MD71F00001VR
Reference: MCL02102E
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 29.06.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792645
Basic UDI-DI: 695441470207H4
Reference: IF5007
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL PCT (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414713510
Basic UDI-DI: B-06954414713510
Reference: /
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702071
Basic UDI-DI: B-06954414702071
Reference: /
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

PCT FIA

PCT-W23F3

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802820
Basic UDI-DI: B-06952804802820
Reference: PCT-W23F3
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

06951045810021

100 tests/ 50 tests

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

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045810021
Basic UDI-DI: 69510458SF_PCTY2
Reference: SDX-57003/SDX-57032
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 28.06.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Test Kit (Immunofluorescence)

25T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334804451
Basic UDI-DI: B-06950334804451
Reference: 52026007
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:40

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590308
Basic UDI-DI: 697518250F1500126
Reference: F15008
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

06941967222590

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967222590
Basic UDI-DI: B-06941967222590
Reference: 01.09.07.01.EC.01
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ B·R·A·H·M·S PCT

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405301
Basic UDI-DI: 69713904310047H
Reference: 011004601
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:07

Manufacturer products Authorised representative products Authorised representative actors View details

06937287300193

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300193
Basic UDI-DI: B-06937287300193
Reference: R1: 2×60 mL, R2: 2×20 mL
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Kit (CLIA)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751680
Basic UDI-DI: B-06936595751680
Reference: FG1470Y
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Kit (Latex-Enhanced Immunoturbidimetric Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595750751
Basic UDI-DI: B-06936595750751
Reference: MJ452Y
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Calibrators

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900632
Basic UDI-DI: 69449040004S-PCT*******M3
Reference: 105-010219-00
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 16:22

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin(CLIA)

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900595
Basic UDI-DI: 69449040004S-PCT*******M3
Reference: 105-010730-00
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 16:22

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: 06925912718420
Basic UDI-DI: 692591270050GY
Reference: C86039
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

Finecare

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289846370
Basic UDI-DI: B-06933289846370
Reference: W210
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details