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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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20.09.2026 13:26

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587 device results listed.

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Prostate Specific Antigen (PSA) Rapid Test Strip (Whole Blood /Serum/Plasma)

GEPSA-401a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEPSA-401aHG7Y
Basic UDI-DI: B-GEPSA-401aHG7Y
Reference: GEPSA-401a
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

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Prostate Specific Antigen (PSA) Rapid Test Cassette (Serum/Plasma)

GEPSA-302a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEPSA-302aHG7S
Basic UDI-DI: B-GEPSA-302aHG7S
Reference: GEPSA-302a
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

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Prostate Specific Antigen (PSA) Rapid Test Strip (Serum/Plasma)

GEPSA-301a

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEPSA-301aHG7K
Basic UDI-DI: B-GEPSA-301aHG7K
Reference: GEPSA-301a
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

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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

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FOB/Transferrin/Adeno/Rota/H. pylori Combo Rapid Test Device (Feces)

GEFTHRA-T636a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFTHRA-T636aHG6E
Basic UDI-DI: B-GEFTHRA-T636aHG6E
Reference: GEFTHRA-T636a
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
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

Fecal Occult Blood and Transferrin Combo Rapid Test Device (Feces)

GEFT-T606a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFT-T606aHGAF
Basic UDI-DI: B-GEFT-T606aHGAF
Reference: GEFT-T606a
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
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

Fecal Occult Blood and Transferrin Combo Rapid Test Cassette (Feces)

GEFOB/TF-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB/TF-602aHGZM
Basic UDI-DI: B-GEFOB/TF-602aHGZM
Reference: GEFOB/TF-602a
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
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

Fecal Occult Blood Rapid Test Device (Feces)

GEFOB-606b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-606bHGWL
Basic UDI-DI: B-GEFOB-606bHGWL
Reference: GEFOB-606b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
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

Fecal Occult Blood Control Kit

GEFOB-PN2

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-PN2HG8H
Basic UDI-DI: B-GEFOB-PN2HG8H
Reference: GEFOB-PN2
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
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

Fecal Occult Blood Rapid Test Cassette (Feces)

GEFOB-602j

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-602jHGWY
Basic UDI-DI: B-GEFOB-602jHGWY
Reference: GEFOB-602j
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
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

Fecal Occult Blood Rapid Test Cassette (Feces)

GEFOB-602c

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-602cHGVV
Basic UDI-DI: B-GEFOB-602cHGVV
Reference: GEFOB-602c
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
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

Fecal Occult Blood Rapid Test Cassette (Feces)

GEFOB-602b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-602bHGVQ
Basic UDI-DI: B-GEFOB-602bHGVQ
Reference: GEFOB-602b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
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

Fecal Occult Blood Rapid Test Cassette (Feces)

GEFOB-602Cb

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-602CbHG2V
Basic UDI-DI: B-GEFOB-602CbHG2V
Reference: GEFOB-602Cb
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
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

Fecal Occult Blood Rapid Test Strip (Feces)

GEFOB-601c

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-601cHGVN
Basic UDI-DI: B-GEFOB-601cHGVN
Reference: GEFOB-601c
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
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

Fecal Occult Blood Rapid Test Strip (Feces)

GEFOB-601b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-601bHGVH
Basic UDI-DI: B-GEFOB-601bHGVH
Reference: GEFOB-601b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
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

Fecal Occult Blood Rapid Test Strip (Feces)

GEFOB-601Cb

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-601CbHG2J
Basic UDI-DI: B-GEFOB-601CbHG2J
Reference: GEFOB-601Cb
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
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 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: 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: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEBTA-102aHGSW
Basic UDI-DI: B-GEBTA-102aHGSW
Reference: GEBTA-102a
EMDN: W0102160201
EMDN description: BTA - RT & POC
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

Alpha-Fetoprotein Rapid Test Cassette (Whole Blood/Serum/Plasma)

GEAFP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEAFP-402aHGS3
Basic UDI-DI: B-GEAFP-402aHGS3
Reference: GEAFP-402a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
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