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Antistreptolysin O Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ASO601CJ
Basic UDI-DI: B-ASO601CJ
Reference: ASO6011Y, ASO6012Y, ASO6013Y, ASO6014Y, ASO6015Y, ASO6011N, ASO6012N, ASO6013N, ASO6014N, ASO6015N
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP Anti-Cyclic Citrullinated Peptides Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ACCP706-AEKR
Basic UDI-DI: B-ACCP706-AEKR
Reference: ACCP706-AE10Y, ACCP706-AE10N, ACCP706-AE20Y, ACCP706-AE20N
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 21:28

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Dr. Max Strep A Test

800060-x

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-888060SZ
Basic UDI-DI: B-888060SZ
Reference: 888060-1
EMDN: W01021111
EMDN description: ANTI-STREPTOCOCCAL SCREENING
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dr.Max+

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-888060-1ER
Basic UDI-DI: B-888060-1ER
Reference: 888060-1CRS
EMDN: W01021111
EMDN description: ANTI-STREPTOCOCCAL SCREENING
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 20:29

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CCP IgG

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147196738
Basic UDI-DI: B-86060147196738
Reference: N702A24IGG
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:14

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RF screen

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147196592
Basic UDI-DI: B-86060147196592
Reference: N706A24RFS
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

ASO Latex Slide

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: MTD Diagnostics srl
Manufacturer SRN: IT-MF-000053242
UDI-DI: 8053617720184
Basic UDI-DI: B-8053617720184
Reference: RT1010
EMDN: W01021105
EMDN description: ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE)
First on market country: Italy
Authorised representative: -
Last updated: 12.07.2026 09:32

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ASO Latex + Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: MTD Diagnostics srl
Manufacturer SRN: IT-MF-000053242
UDI-DI: 80536177201772B
Basic UDI-DI: B-80536177201772B
Reference: TB1000
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Italy
Authorised representative: -
Last updated: 12.07.2026 09:32

Manufacturer products View details

D-800060-20PZT

800060-xP

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-800060-20PZT
Basic UDI-DI: B-800060-20PZT
Reference: 800060RH-20P-MY
EMDN: W01021111
EMDN description: ANTI-STREPTOCOCCAL SCREENING
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

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PRIMA HOME TEST

800060-x

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-800060-1CS3M
Basic UDI-DI: B-800060-1CS3M
Reference: 800060-1
EMDN: W01021111
EMDN description: ANTI-STREPTOCOCCAL SCREENING
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7M26FE
Basic UDI-DI: B-7M26FE
Reference: 7M26V1-B-EU, 7M26U1-B-EU, 7M26P1-B-EU
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7M24FA
Basic UDI-DI: B-7M24FA
Reference: 7M24V1-B-EU, 7M24U1-B-EU, 7M24P1-B-EU
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D CRP

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77805JW
Basic UDI-DI: B-77805JW
Reference: 77805
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:24

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM i-Pack CRP Wide

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77610JD
Basic UDI-DI: B-77610JD
Reference: 77610
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (eCLIA)

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063522
Basic UDI-DI: 69703416803205023J7
Reference: 0320502002
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (eCLIA)

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063539
Basic UDI-DI: 69703416803205023J7
Reference: 0320502003
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (eCLIA)

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063546
Basic UDI-DI: 69703416803205023J7
Reference: 0320502004
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.07.2026 09:10

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IMMAGE Immunochemistry Systems High Sensitivity C-reactive Protein (CRPH) Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474630QT
Basic UDI-DI: B-474630QT
Reference: 474630
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

Antistreptolysin-O Reagent (ASO- 2 x 100)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469165RD
Basic UDI-DI: B-469165RD
Reference: 469165
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447280QA
Basic UDI-DI: B-447280QA
Reference: 447280
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details