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699 device results listed.

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PCT (Procalcitonin) Rapid Quantitative Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: D-300021BUN
Basic UDI-DI: B-300021BUN
Reference: HU-RE-F07F046001
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

PCT (Procalcitonin) Rapid Quantitative Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490466
Basic UDI-DI: B-06975679490466
Reference: HU-RE-F07F046002
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 12.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858885
Basic UDI-DI: B-06933289858885
Reference: WA26P0006
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858878
Basic UDI-DI: B-06933289858878
Reference: WA26P0005
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858861
Basic UDI-DI: B-06933289858861
Reference: WA26P0004
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858854
Basic UDI-DI: B-06933289858854
Reference: WA26P0003
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Gastrin-17 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858151
Basic UDI-DI: B-06933289858151
Reference: W492P0005
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Gastrin-17 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858144
Basic UDI-DI: B-06933289858144
Reference: W492P0004
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Gastrin-17 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858137
Basic UDI-DI: B-06933289858137
Reference: W492P0003
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Gastrin-17 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858120
Basic UDI-DI: B-06933289858120
Reference: W492P0002
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208470
Basic UDI-DI: B-06933260208470
Reference: BT2301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 09.08.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (Electrochemiluminescence Immunoassay)

100T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341680596
Basic UDI-DI: B-06970341680596
Reference: 689013
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (Electrochemiluminescence Immunoassay)

2×100T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341681005
Basic UDI-DI: B-06970341681005
Reference: 689014
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (Electrochemiluminescence Immunoassay)

50T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341689179
Basic UDI-DI: B-06970341689179
Reference: 50T
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM DHEAS2

IVDR_67_TTN_DUB-C_B_REAG_KIT_DHEAS2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414632926
Basic UDI-DI: 0405686902311V5
Reference: 11209193
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL, Calibration sample: 5x1mL, Control: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239434
Basic UDI-DI: B-06942202239434
Reference: 3012874
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x30mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239441
Basic UDI-DI: B-06942202239441
Reference: 3012844
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-++B261CANL4260DA

CAN-L-4260

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: D-++B261CANL4260DA
Basic UDI-DI: B-++B261CANL4260DA
Reference: CAN-L-4260
EMDN: W0102069014
EMDN description: LEPTIN
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 06.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Procalcitonin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857758
Basic UDI-DI: B-06933289857758
Reference: W388P0007
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Procalcitonin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857741
Basic UDI-DI: B-06933289857741
Reference: W388P0006
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details