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699 device results listed.

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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

SmarLumi

Procalcitonin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857734
Basic UDI-DI: B-06933289857734
Reference: W388P0005
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: 06933289857727
Basic UDI-DI: B-06933289857727
Reference: W388P0004
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

ADVIA Centaur Androstenedione (ANDRO)

IVDR_67_TTN_DUB-C_B_KIT_ANDRO

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414603445
Basic UDI-DI: 0405686901601VA
Reference: 10997290
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen II (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858922
Basic UDI-DI: B-06933289858922
Reference: WA27P0006
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:23

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen II (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858915
Basic UDI-DI: B-06933289858915
Reference: WA27P0005
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:23

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen II (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858908
Basic UDI-DI: B-06933289858908
Reference: WA27P0004
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:23

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pepsinogen II (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858892
Basic UDI-DI: B-06933289858892
Reference: WA27P0003
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:23

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for β-HCG

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315809
Basic UDI-DI: B-04260163315809
Reference: 07HCG5025
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products View details

Diagnostic Kit for Procalcitonin (PCT)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315793
Basic UDI-DI: B-04260163315793
Reference: 07PCT5025
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products 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: 06942202239410
Basic UDI-DI: B-06942202239410
Reference: 3011463
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

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: 06942202239427
Basic UDI-DI: B-06942202239427
Reference: 3011534
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

06955792741270

Gastrin-17 Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792741270
Basic UDI-DI: B-06955792741270
Reference: S2118E-48
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

06955792741263

Gastrin-17 Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792741263
Basic UDI-DI: B-06955792741263
Reference: S2118E-24
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

06955792741195

Pepsinogen II Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792741195
Basic UDI-DI: B-06955792741195
Reference: S2114E-48
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

06955792741188

Pepsinogen II Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792741188
Basic UDI-DI: B-06955792741188
Reference: S2114E-24
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

06955792741171

Pepsinogen I Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792741171
Basic UDI-DI: B-06955792741171
Reference: S2113E-48
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details