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52 device results listed.

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D-CNMF000014455-BF-S045RM

BF S04

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S045RM
Basic UDI-DI: B-CNMF000014455-BF-S045RM
Reference: BF-S045
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S044RK

BF S04

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S044RK
Basic UDI-DI: B-CNMF000014455-BF-S044RK
Reference: BF-S044
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S043RH

BF S04

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S043RH
Basic UDI-DI: B-CNMF000014455-BF-S043RH
Reference: BF-S043
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S042RF

BF S04

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S042RF
Basic UDI-DI: B-CNMF000014455-BF-S042RF
Reference: BF-S042
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S041RD

BF S04

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S041RD
Basic UDI-DI: B-CNMF000014455-BF-S041RD
Reference: BF-S041
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Streptolysin O Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5M28C2ZU
Basic UDI-DI: B-5M28C2ZU
Reference: 5M28C2-25-EU, 5M28C2-50-EU
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5M24C2Z8
Basic UDI-DI: B-5M24C2Z8
Reference: 5M24C2-25-EU, 5M24C2-50-EU
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

Interleukin-6 Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5M20C2YL
Basic UDI-DI: B-5M20C2YL
Reference: 5M20C2-25-EU, 5M20C2-50-EU
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

SAA Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SAA-D06aB3
Basic UDI-DI: B-SAA-D06aB3
Reference: SAA -D06a
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

SAA Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SAA-D02aAP
Basic UDI-DI: B-SAA-D02aAP
Reference: SAA-D02a
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

PCT/IL-6 Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PCT/IL-6-D26a9Q
Basic UDI-DI: B-PCT/IL-6-D26a9Q
Reference: PCT/IL-6-D26a
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PCT-D06aJ3
Basic UDI-DI: B-PCT-D06aJ3
Reference: B-PCT-D06aJ3
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PCT-D02aHP
Basic UDI-DI: B-PCT-D02aHP
Reference: PCT-D02a
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

InfectCheck PCT

PCT Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-K12-PCTGN
Basic UDI-DI: B-K12-PCTGN
Reference: K12-PCT
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

InfectCheck NeoPT (quantitative)

NeoPT Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-K12-NEOG8
Basic UDI-DI: B-K12-NEOG8
Reference: K12-NEO
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

CRP/SAA Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-CRP/SAA-D26aCN
Basic UDI-DI: B-CRP/SAA-D26aCN
Reference: CRP/SAA-D26a
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 07:20

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell®Calprotectin Semi-Quantitative Cassette(Feces)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-INF-B299VN
Basic UDI-DI: B-ABT-INF-B299VN
Reference: ABT-INF-B299
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® PCT Semi-Quantitative Strip(Whole Blood/Serum/Plasma)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A266VC
Basic UDI-DI: B-ABT-IDT-A266VC
Reference: ABT-IDT-A266
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-808163QL

PCT/IL-6 Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808163QL
Basic UDI-DI: B-808163QL
Reference: 808163
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-808160QE

IL-6 Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808160QE
Basic UDI-DI: B-808160QE
Reference: 808160
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details