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06928103000625

Single tube, 20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103000625
Basic UDI-DI: B-06928103000625
Reference: DA0062
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103000618

Single tube, 20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103000618
Basic UDI-DI: B-06928103000618
Reference: DA0061
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103000601

Single tube, 20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103000601
Basic UDI-DI: B-06928103000601
Reference: DA0060
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103000526

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103000526
Basic UDI-DI: B-06928103000526
Reference: DA0052
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103000519

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103000519
Basic UDI-DI: B-06928103000519
Reference: DA0051
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103000502

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103000502
Basic UDI-DI: B-06928103000502
Reference: DA0050
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06928103000410

Large package, 48 tests/kit

IVD Annex II List AIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103000410
Basic UDI-DI: B-06928103000410
Reference: DA0041
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Slovakia
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

06926980316778

Diagnostic Kit for rLKS(IFA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980316778
Basic UDI-DI: B-06926980316778
Reference: CK-2208-100G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 03.08.2026 12:19

Manufacturer products Authorised representative products Authorised representative actors View details

06926980316761

Diagnostic Kit for rLKS(IFA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980316761
Basic UDI-DI: B-06926980316761
Reference: CK-2208-050G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 03.08.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

06926980312404

Diagnostic Kit for ANCA (Formalin)(IFA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980312404
Basic UDI-DI: B-06926980312404
Reference: CK-2204-120G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 03.08.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

06926980312398

Diagnostic Kit for ANCA (Formalin)(IFA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980312398
Basic UDI-DI: B-06926980312398
Reference: CK-2204-060G
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 03.08.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

06926980312381

Diagnostic Kit for ANCA (Ethanol)(IFA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980312381
Basic UDI-DI: B-06926980312381
Reference: CK-2203-120G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 03.08.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

06926980312374

Diagnostic Kit for ANCA (Ethanol) (IFA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980312374
Basic UDI-DI: B-06926980312374
Reference: CK-2203-060G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 03.08.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

06926980312367

Diagnostic Kit for Anti-dsDNA IgG(IFA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980312367
Basic UDI-DI: B-06926980312367
Reference: CK-2202-120G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 03.08.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

06926980312350

Diagnostic Kit for Anti-dsDNA IgG(IFA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980312350
Basic UDI-DI: B-06926980312350
Reference: CK-2202-060G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 03.08.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

06926980312343

Diagnostic Kit for ANA (IFA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980312343
Basic UDI-DI: B-06926980312343
Reference: CK-2201-120G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 03.08.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

06926980312336

Diagnostic Kit for ANA (IFA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980312336
Basic UDI-DI: B-06926980312336
Reference: CK-2201-060G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 03.08.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

Functional Fibrinogen Assay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604809
Basic UDI-DI: B-06926802604809
Reference: MCT00603E
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Functional Fibrinogen Assay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604793
Basic UDI-DI: B-06926802604793
Reference: MCT00602E
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Heparin Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604786
Basic UDI-DI: B-06926802604786
Reference: MCT00304E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details