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D-CK-2485-100G8D

Human anti-CA6 antibody CLIA Kit (IgG)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2485-100G8D
Basic UDI-DI: B-CK-2485-100G8D
Reference: CK-2485-100G
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-CK-2485-100A7Z

Human anti-CA6 antibody CLIA Kit (IgA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2485-100A7Z
Basic UDI-DI: B-CK-2485-100A7Z
Reference: CK-2485-100A
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-CK-2485-050M9B

Human anti-CA6 antibody CLIA Kit (IgM)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2485-050M9B
Basic UDI-DI: B-CK-2485-050M9B
Reference: CK-2485-050M
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-CK-2485-050G8X

Human anti-CA6 antibody CLIA Kit (IgG)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2485-050G8X
Basic UDI-DI: B-CK-2485-050G8X
Reference: CK-2485-050G
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-CK-2485-050A8K

Human anti-CA6 antibody CLIA Kit (IgA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2485-050A8K
Basic UDI-DI: B-CK-2485-050A8K
Reference: CK-2485-050A
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-CK-2484-100M8C

Human anti-parotid secretory protein antibody CLIA Kit (IgM)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2484-100M8C
Basic UDI-DI: B-CK-2484-100M8C
Reference: CK-2484-100M
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-CK-2484-100G7Y

Human anti-parotid secretory protein antibody CLIA Kit (IgG)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2484-100G7Y
Basic UDI-DI: B-CK-2484-100G7Y
Reference: CK-2484-100G
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-CK-2484-100A7L

Human anti-parotid secretory protein antibody CLIA Kit (IgA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2484-100A7L
Basic UDI-DI: B-CK-2484-100A7L
Reference: CK-2484-100A
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-CK-2484-050M8W

Human anti-parotid secretory protein antibody CLIA Kit (IgM)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2484-050M8W
Basic UDI-DI: B-CK-2484-050M8W
Reference: CK-2484-050M
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-CK-2484-050G8J

Human anti-parotid secretory protein antibody CLIA Kit (IgG)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2484-050G8J
Basic UDI-DI: B-CK-2484-050G8J
Reference: CK-2484-050G
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

D-CK-2484-050A86

Human anti-parotid secretory protein antibody CLIA Kit (IgA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: D-CK-2484-050A86
Basic UDI-DI: B-CK-2484-050A86
Reference: CK-2484-050A
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 13.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TSHR Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC370QN
Basic UDI-DI: B-CC370QN
Reference: CC370
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-RNP70 IgG

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-C89045GC3
Basic UDI-DI: B-C89045GC3
Reference: C89045G
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-Anti-ETARABEK

Anti-ETAR AB

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: CellTrend GmbH
Manufacturer SRN: DE-MF-000030872
UDI-DI: D-Anti-ETARABEK
Basic UDI-DI: B-Anti-ETARABEK
Reference: 12100
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 12.07.2026 21:46

Manufacturer products View details

Anti-Neutrophil Cytoplasmic Antibody (Formalin Fixed)

A060PL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ZEUS Scientific
Manufacturer SRN: US-MF-000026845
UDI-DI: D-A060PLX4
Basic UDI-DI: B-A060PLX4
Reference: A060PL
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Neutrophil Cytoplasmic Antibody (Ethanol Fixed)

A060L

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ZEUS Scientific
Manufacturer SRN: US-MF-000026845
UDI-DI: D-A060LMJ
Basic UDI-DI: B-A060LMJ
Reference: A060L
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Lysozyme

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313276226
Basic UDI-DI: B-86060313276226
Reference: C1815LYS
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

Zonulin

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313276080
Basic UDI-DI: B-86060313276080
Reference: C1826ZON
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

β-Defensin

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275922
Basic UDI-DI: B-86060313275922
Reference: C1818DEF
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

EDN

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313275236
Basic UDI-DI: B-86060313275236
Reference: C1819EDN
EMDN: W0102100899
EMDN description: OTHERS INFLAMATORY BOWEL DISEASE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details