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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)

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)

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)

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

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

GECEA-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GECEA-401aHGJ2
Basic UDI-DI: B-GECEA-401aHGJ2
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

Bladder Tumor Antigen Rapid Test Cassette (Urine)

GEBTA-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEBTA-102aWA
Basic UDI-DI: B-GEBTA-102aWA
Reference: GEBTA-102a
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Prostate-Specific Antigen (PSA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599816
Basic UDI-DI: 0405686901820VQ
Reference: 10995663
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Prostate-Specific Antigen (PSA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599809
Basic UDI-DI: 0405686901820VQ
Reference: 10995662
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Quantitative Test Kit (Time-Resolved FIA)

FECEA-402a

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FECEA-402aNN
Basic UDI-DI: B-FECEA-402aNN
Reference: FECEA-402a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Quantitative Test Kit (Time-Resolved FIA)

FECEA-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FECEA-402aHGH4
Basic UDI-DI: B-FECEA-402aHGH4
Reference: FECEA-402a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4407107GL

IVD Annex II List BNot specifiedOn the market

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4407107GL
Basic UDI-DI: B-EIM4407107GL
Reference: EIM4407107
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4407106GJ

IVD Annex II List BNot specifiedOn the market

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4407106GJ
Basic UDI-DI: B-EIM4407106GJ
Reference: EIM4407106
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4406107GD

IVD Annex II List BNot specifiedOn the market

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4406107GD
Basic UDI-DI: B-EIM4406107GD
Reference: EIM4406107
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4406106GB

IVD Annex II List BNot specifiedOn the market

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4406106GB
Basic UDI-DI: B-EIM4406106GB
Reference: EIM4406106
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4405107G6

IVD Annex II List BNot specifiedOn the market

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4405107G6
Basic UDI-DI: B-EIM4405107G6
Reference: EIM4405107
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details