Veriler yükleniyor…

Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

03.08.2026 18:01

Sync status

Successful

Device

2994157

Actor

47526

Certificate

3176

Filters

Show filters

Active filter:EMDN:W01020301

1000+ device results listed.

Page 15 / 50

D-697994388Ir0523FDA

CEA Carcinoma Embryonic Ag Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0523FDA
Basic UDI-DI: B-697994388Ir0523FDA
Reference: Ir052
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0513DCZ

AFP Alpha Fetoprotein Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0513DCZ
Basic UDI-DI: B-697994388Ir0513DCZ
Reference: Ir051
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

CEA (Carcinoembryonic Antigen) Rapid Test

CEA (Carcinoembryonic Antigen) Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309676
Basic UDI-DI: B-69743840309676
Reference: 3040601
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

PSA Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840308136
Basic UDI-DI: B-69743840308136
Reference: 3040301
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate Specific Antigen (PSA) Test

strip cassette

IVD Annex II List BIVDDOn the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990607QK
Basic UDI-DI: B-693757990607QK
Reference: strip cassette
EMDN: W0102030122
EMDN description: EARLY PROSTATE CANCER ANTIGEN - 2
First on market country: Northern Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-81AL
Basic UDI-DI: B-6-81AL
Reference: "REF: USIA00000133M, USIA00000134M"
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Pro-gastrin-releasing Peptide (proGRP) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-80AJ
Basic UDI-DI: B-6-80AJ
Reference: "REF: USIA00000145M, USIA00000146M"
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen (CEA) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-79AZ
Basic UDI-DI: B-6-79AZ
Reference: "REF: USIA00000127M, USIA00000128M"
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 72-4 (CA72-4) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-76AT
Basic UDI-DI: B-6-76AT
Reference: "REF: USIA00000135M, USIA00000136M"
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 50 (CA50) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-75AR
Basic UDI-DI: B-6-75AR
Reference: "REF: USIA00000137M, USIA00000138M"
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 125 (CA125) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-74AP
Basic UDI-DI: B-6-74AP
Reference: "REF: USIA00000129M, USIA00000130M"
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 15-3(CA15-3)Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-73AM
Basic UDI-DI: B-6-73AM
Reference: "REF: USIA00000131M, USIA00000132M"
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Squamous Cell Carcinoma Antigen (SCCA) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-72AK
Basic UDI-DI: B-6-72AK
Reference: "REF: USIA00000141M, USIA00000142M"
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymis Protein 4 (HE4) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-70AF
Basic UDI-DI: B-6-70AF
Reference: "REF: USIA00000151M, USIA00000152M"
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 242 (CA242) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-69AW
Basic UDI-DI: B-6-69AW
Reference: "REF: USIA00000139M, USIA00000140M"
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 19 Fragment (CYFRA21-1) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-68AU
Basic UDI-DI: B-6-68AU
Reference: "REF: USIA00000149M, USIA00000150M"
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Tumor Antigen Rapid Test

VTBTA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210821
Basic UDI-DI: B-06937339210821
Reference: VTBTA-102
EMDN: W0102030101
EMDN description: BLADDER TUMOUR ANTIGEN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Cyfra21-1

AFIAS Cyfra21-1

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043967
Basic UDI-DI: 880613300640CD
Reference: SMFP-135
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS CA19-9

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043875
Basic UDI-DI: 880613300639CU
Reference: SMFP-134
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Free PSA

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043783
Basic UDI-DI: 880613300646CR
Reference: SMFP-170
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details