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EUDAMED Device Search

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

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03.08.2026 06:01

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Reagents (include Calibrator and Control): 100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719600687
Basic UDI-DI: B-06972719600687
Reference: 215880001
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:32

Manufacturer products Authorised representative products Authorised representative actors View details

Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719600670
Basic UDI-DI: B-06972719600670
Reference: 215100009
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:32

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen (CEA) Assay Reagent Kit (CMIA)

C2KA005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792054493
Basic UDI-DI: B-06971792054493
Reference: C2KA005
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:57

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 125 (CA125) Assay Reagent Kit (CMIA)

C2KA004

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792054455
Basic UDI-DI: B-06971792054455
Reference: C2KA004
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:57

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9(CA19-9) Assay Reagent Kit(CMIA)

C2KA003

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792054417
Basic UDI-DI: B-06971792054417
Reference: C2KA003
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:57

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 15-3 (CA15-3) Assay Reagent Kit (CMIA)

C2KA002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792054370
Basic UDI-DI: B-06971792054370
Reference: C2KA002
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 13:57

Manufacturer products Authorised representative products Authorised representative actors View details

Squamous Cell Carcinoma Antigen (SCCA) Assay Reagent Kit

C2KA012

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053373
Basic UDI-DI: B-06971792053373
Reference: C2KA012
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

CYFRA 21-1 Assay Reagent Kit (CMIA)

C2KA007

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053335
Basic UDI-DI: B-06971792053335
Reference: C2KA007
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue polypeptide antigen(TPA) Assay Reagent Kit (CMIA)

C2KA023

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051454
Basic UDI-DI: B-06971792051454
Reference: C2KA023
EMDN: W0102030117
EMDN description: TUMOR POLYPEPTIDE ANTIGEN (TPA - INCL. TPS)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

Prostatic acid phosphatasec Assay Reagent Kit

C2KA020

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051331
Basic UDI-DI: B-06971792051331
Reference: C2KA020
EMDN: W0102030120
EMDN description: PROSTATIC ACID PHOSPHATASE (IC)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate antigen 72-4 Assay Reagent Kit (CMIA)

C2KA019

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051294
Basic UDI-DI: B-06971792051294
Reference: C2KA019
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate antigen 242 Assay Reagent Kit (CMIA)

C2KA018

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051256
Basic UDI-DI: B-06971792051256
Reference: C2KA018
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate antigen 50 Assay Reagent Kit (CMIA)

C2KA017

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051218
Basic UDI-DI: B-06971792051218
Reference: C2KA017
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

Pro-Gastrin Releasing Peptide (ProGRP) Assay Reagent Kit (CMIA)

C2KA013

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792051133
Basic UDI-DI: B-06971792051133
Reference: C2KA013
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymis Protein 4 (HE4) Assay Reagent Kit (CMIA)

C2KA006

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792050938
Basic UDI-DI: B-06971792050938
Reference: C2KA006
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:53

Manufacturer products Authorised representative products Authorised representative actors View details

Free Prostate Specific Antigen (f-PSA) Diagnostic Kit

Free Prostate Specific Antigen (f-PSA) Diagnostic Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762179
Basic UDI-DI: B-06971348762179
Reference: MF-47-25
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Free Prostate Specific Antigen (f-PSA) Diagnostic Kit

Free Prostate Specific Antigen (f-PSA) Diagnostic Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760113
Basic UDI-DI: B-06971348760113
Reference: MF-47-20
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate Specific Antigen (PSA) Diagnostic Kit

Prostate Specific Antigen (PSA) Diagnostic Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760106
Basic UDI-DI: B-06971348760106
Reference: MF-46-20
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

PSA Rapid Test

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983119047
Basic UDI-DI: B-06936983119047
Reference: TPS-402
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen (CLIA)

-

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904047881
Basic UDI-DI: 69449040004H-CEA*******JM
Reference: 105-004240-00
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details