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CA 50 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403110HD
Basic UDI-DI: B-IM4403110HD
Reference: IM4403110
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

CYFRA21-1 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403109HU
Basic UDI-DI: B-IM4403109HU
Reference: IM4403109
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

PIVKA-II Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402129HT
Basic UDI-DI: B-IM4402129HT
Reference: IM4402129
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

HE4 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402115HG
Basic UDI-DI: B-IM4402115HG
Reference: IM4402115
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

CA 242 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402114HE
Basic UDI-DI: B-IM4402114HE
Reference: IM4402114
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

CA 72-4 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402113HC
Basic UDI-DI: B-IM4402113HC
Reference: IM4402113
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

proGRP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402112HA
Basic UDI-DI: B-IM4402112HA
Reference: IM4402112
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

SCC Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402111H8
Basic UDI-DI: B-IM4402111H8
Reference: IM4402111
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

CA 50 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402110H6
Basic UDI-DI: B-IM4402110H6
Reference: IM4402110
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

CYFRA21-1 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402109HM
Basic UDI-DI: B-IM4402109HM
Reference: IM4402109
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

HE4 Human Epididymal Protein 4 (CLIA)

HE4 Human Epididymal Protein 4 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HE4706-AEFT
Basic UDI-DI: B-HE4706-AEFT
Reference: HE4706-AE10Y, HE4706-AE10N, HE4706-AE20Y, HE4706-AE20N
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:53

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 Detection Kit (Immunofluorescence Chromatography)

CA125 Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD188Y6
Basic UDI-DI: B-GKPD188Y6
Reference: GKPD188
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 Detection Kit (Immunofluorescence Chromatography)

CA19-9 Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD187Y4
Basic UDI-DI: B-GKPD187Y4
Reference: GKPD187
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Detection Kit (Immunofluorescence Chromatography)

CA15-3 Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD186Y2
Basic UDI-DI: B-GKPD186Y2
Reference: GKPD186
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Detection Kit (Immunofluorescence Chromatography)

CEA Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD182XS
Basic UDI-DI: B-GKPD182XS
Reference: GKPD182
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Nuclear Matrix Protein 22 Test Cassette (Urine)

GENMP22-102a

IVD generalIVDDOn the marketAnimal tissuesKitSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GENMP22-102aHGGZ
Basic UDI-DI: B-GENMP22-102aHGGZ
Reference: GENMP22-102a
EMDN: W0102030123
EMDN description: NUCLEAR MATRIX PROTEIN 22
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Nuclear Matrix Protein 22 Test Cassette (Urine)

GENMP22-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GENMP22-102a47
Basic UDI-DI: B-GENMP22-102a47
Reference: GENMP22-102a
EMDN: W0102030123
EMDN description: NUCLEAR MATRIX PROTEIN 22
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)

GECEA-402a

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GECEA-402aPK
Basic UDI-DI: B-GECEA-402aPK
Reference: GECEA-402a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)

GECEA-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GECEA-402aHGJ9
Basic UDI-DI: B-GECEA-402aHGJ9
Reference: GECEA-402a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma)

GECEA-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GECEA-401aPG
Basic UDI-DI: B-GECEA-401aPG
Reference: GECEA-401a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details