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EUDAMED Device Search

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

Last updated

02.08.2026 12:03

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1000+ device results listed.

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IVD generalNot specifiedOn the market

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627006370
Basic UDI-DI: B-00847627006370
Reference: CM131A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Greece
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD generalNot specifiedOn the market

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627006332
Basic UDI-DI: B-00847627006332
Reference: CM129CK
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

CM129BK

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627006325
Basic UDI-DI: B-00847627006325
Reference: CM129BK
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

CM129AK

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627006318
Basic UDI-DI: B-00847627006318
Reference: CM129AK
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

CM123A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627006257
Basic UDI-DI: B-00847627006257
Reference: CM123A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Breast Cocktail(CKHMW/p63+CK7/8/18)

AVI3203DSKG

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005014
Basic UDI-DI: B-00847627005014
Reference: AVI3203DSKG
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Poland
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

API3117AA

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627004222
Basic UDI-DI: B-00847627004222
Reference: API3117AA
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3117B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627003072
Basic UDI-DI: B-00847627003072
Reference: ACI3117B
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ACI3117A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627003065
Basic UDI-DI: B-00847627003065
Reference: ACI3117A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Lumipulse G pTau 217 Plasma Immunoreaction Cartridges <3x14T, CE>

81544

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Fujirebio Europe N.V.
Manufacturer SRN: BE-MF-000001792
UDI-DI: 05414470815449
Basic UDI-DI: 541447003155
Reference: 81544
EMDN: W0102019017
EMDN description: PHOSPHORYLATED TAU (PTAU)
First on market country: Belgium
Authorised representative: -
Last updated: 01.08.2026 20:16

Manufacturer products View details

Lumipulse G pTau 217 Plasma Calibrators <1x5C, CE>

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IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Fujirebio Europe N.V.
Manufacturer SRN: BE-MF-000001792
UDI-DI: 05414470815456
Basic UDI-DI: 541447003155
Reference: 81545
EMDN: W0102019017
EMDN description: PHOSPHORYLATED TAU (PTAU)
First on market country: Belgium
Authorised representative: -
Last updated: 01.08.2026 20:16

Manufacturer products View details

Lumipulse pTau 217 Plasma Controls <2x2C, CE>

81546

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Fujirebio Europe N.V.
Manufacturer SRN: BE-MF-000001792
UDI-DI: 05414470815463
Basic UDI-DI: 54144700375H
Reference: 81546
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Belgium
Authorised representative: -
Last updated: 01.08.2026 20:16

Manufacturer products View details

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IVD self-testing devicesNot specifiedNo longer on the market

Manufacturer: Beijing Yicheng Bioelectronics Technology Co., Ltd.
Manufacturer SRN: CN-MF-000033130
UDI-DI: 06914329008811
Basic UDI-DI: B-06914329008811
Reference: Model mALB-1：125000007、Model mALB-2：125000009、Model mALB-3：125000008
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: -
Authorised representative: Caretechion GmbH
Last updated: 01.08.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: GA Generic Assays GmbH
Manufacturer SRN: DE-MF-000032990
UDI-DI: 04250310703962
Basic UDI-DI: B-04250310703962
Reference: 3665
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: -
Last updated: 01.08.2026 13:58

Manufacturer products View details

Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method)

Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656962
Basic UDI-DI: B-00810173656962
Reference: 1IF4B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method)

Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656924
Basic UDI-DI: B-00810173656924
Reference: 1TM2B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method)

Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656917
Basic UDI-DI: B-00810173656917
Reference: 1GF3B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)

Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656900
Basic UDI-DI: B-00810173656900
Reference: 1AA15B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method)

Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656894
Basic UDI-DI: B-00810173656894
Reference: 1TM6B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method)

Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656887
Basic UDI-DI: B-00810173656887
Reference: 1TM7B01
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details