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61 device results listed.

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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

D-808162QJ

CRP/SAA 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-808162QJ
Basic UDI-DI: B-808162QJ
Reference: 808162
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-808161QG

SAA 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-808161QG
Basic UDI-DI: B-808161QG
Reference: 808161
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-808158QT

PCT 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-808158QT
Basic UDI-DI: B-808158QT
Reference: 808158
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

Rapid Anti-CCP Antibody Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-1M26C2XW
Basic UDI-DI: B-1M26C2XW
Reference: 1M26C2-1-EU, 1M26C2-25-EU
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 11.07.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

TruCell

SAA Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245257
Basic UDI-DI: B-15065026245257
Reference: TC60004
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

PCT/CRP (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763518
Basic UDI-DI: B-15065023763518
Reference: TV20013
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

SAA Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763501
Basic UDI-DI: B-15065023763501
Reference: TV20012
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

CalproSmart Self-Test

CAL201

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Calpro AS
Manufacturer SRN: NO-MF-000036194
UDI-DI: 07090028592017
Basic UDI-DI: B-07090028592017
Reference: CAL201
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Norway
Authorised representative: -
Last updated: 07.07.2026 02:57

Manufacturer products View details

06978189070913

10tests/kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Yantai JIEZI Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000044146
UDI-DI: 06978189070913
Basic UDI-DI: B-06978189070913
Reference: 10tests/kit
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

06977194142318

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen BioRay Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045502
UDI-DI: 06977194142318
Basic UDI-DI: B-06977194142318
Reference: HR0520003
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details