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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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D-CNMF000014455-BF-S232RN

BF S23

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S232RN
Basic UDI-DI: B-CNMF000014455-BF-S232RN
Reference: BF-S232
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-S231RL

BF S23

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-S231RL
Basic UDI-DI: B-CNMF000014455-BF-S231RL
Reference: BF-S231
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Bladder Cancer Marker NMP22 Test

INDICAID™ Bladder Cancer Marker NMP22 Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A038D8
Basic UDI-DI: B-A038D8
Reference: INDICAID™ Bladder Cancer Marker NMP22 Test
EMDN: W0102030123
EMDN description: NUCLEAR MATRIX PROTEIN 22
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0773XFM

CRP/PCT Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0773XFM
Basic UDI-DI: B-697994388Ir0773XFM
Reference: Ir077
EMDN: W0102030399
EMDN description: OTHER ONCOPROTEINS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0763VFC

CRP/SAA Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0763VFC
Basic UDI-DI: B-697994388Ir0763VFC
Reference: Ir076
EMDN: W0102030399
EMDN description: OTHER ONCOPROTEINS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0743RES

SAA Serum Amyloid A Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0743RES
Basic UDI-DI: B-697994388Ir0743RES
Reference: Ir074
EMDN: W0102030399
EMDN description: OTHER ONCOPROTEINS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0733PEH

PCT Procalcitonin Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0733PEH
Basic UDI-DI: B-697994388Ir0733PEH
Reference: Ir073
EMDN: W0102030399
EMDN description: OTHER ONCOPROTEINS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0753TF3

IL-6 Interleukin-6 Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0753TF3
Basic UDI-DI: B-697994388Ir0753TF3
Reference: Ir075
EMDN: W0102030399
EMDN description: OTHER ONCOPROTEINS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0723ME6

hs-CRP High Sensitivity C-Reactive Protein Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0723ME6
Basic UDI-DI: B-697994388Ir0723ME6
Reference: Ir072
EMDN: W0102030399
EMDN description: OTHER ONCOPROTEINS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0713KDV

CRP C-Reactive Protein Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0713KDV
Basic UDI-DI: B-697994388Ir0713KDV
Reference: Ir071
EMDN: W0102030399
EMDN description: OTHER ONCOPROTEINS
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0553ME7

Human Bladder Tumor Antigen (BTA) Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0553ME7
Basic UDI-DI: B-697994388Ir0553ME7
Reference: Ir055
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-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

AFP Rapid Test Device

AFP Rapid Test Device

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: 69743840304176
Basic UDI-DI: B-69743840304176
Reference: 3040401
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

FOB 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: 69743840303186
Basic UDI-DI: B-69743840303186
Reference: 3040101
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood(FOB) Rapid Test (Feces)

Fecal Occult Blood(FOB) Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FOB001GESV
Basic UDI-DI: B-697424646FOB001GESV
Reference: FOB-5011/FOB-5012
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

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

Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)

Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-63H50TSCTE
Basic UDI-DI: B-63H50TSCTE
Reference: 63H50TSC
EMDN: W0102039018
EMDN description: ALPHA-FUCOSIDASE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 03:41

Manufacturer products Authorised representative products Authorised representative actors View details