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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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581 device results listed.

Page 9 / 30

Dengue NS1 Ag Rapid Test Cassette(Whole Blood/Serum/Plasma)

GCDEN(NS)-402d

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCDEN(NS)-402dHG3E
Basic UDI-DI: B-GCDEN(NS)-402dHG3E
Reference: GCDEN(NS)-402d
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

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Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCDEN(NS)-402c

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCDEN(NS)-402cHG39
Basic UDI-DI: B-GCDEN(NS)-402cHG39
Reference: GCDEN(NS)-402c
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

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Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)

GCCr(Ag)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCr(Ag)-402aHGDP
Basic UDI-DI: B-GCCr(Ag)-402aHGDP
Reference: GCCr(Ag)-402a
EMDN: W0105060303
EMDN description: CRYPTOCOCCUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

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CARBA 5 In 1 Rapid Test Cassette

GCCRE-T1402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCRE-T1402aHGFX
Basic UDI-DI: B-GCCRE-T1402aHGFX
Reference: GCCRE-T1402a
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

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COVID-19 IgG/IgM CONTROL Kit

GCCOV-PN20

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-PN20HGJA
Basic UDI-DI: B-GCCOV-PN20HGJA
Reference: GCCOV-PN20
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:25

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COVID-19 IgG/IgM CONTROL Kit

GCCOV-PN10

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-PN10HGJ3
Basic UDI-DI: B-GCCOV-PN10HGJ3
Reference: GCCOV-PN10
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Digital COVID-19 Ag Rapid Test (Swab)

GCCOV-D503a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-D503aHGGU
Basic UDI-DI: B-GCCOV-D503aHGGU
Reference: GCCOV-D503a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Ag Rapid Test Cassette (Oral Fluid)

GCCOV-702a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-702aHG5A
Basic UDI-DI: B-GCCOV-702aHG5A
Reference: GCCOV-702a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Smart Rapid COVID-19 Ag Test Device

GCCOV-503a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-503aHG4P
Basic UDI-DI: B-GCCOV-503aHG4P
Reference: GCCOV-503a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Coronavirus Ag Rapid Test Cassette (Swab)

GCCOV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502aHG4G
Basic UDI-DI: B-GCCOV-502aHG4G
Reference: GCCOV-502a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Coronavirus Ag Rapid Test Cassette (Swab)

GCCOV-502a-NN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-NNHGWZ
Basic UDI-DI: B-GCCOV-502a-NNHGWZ
Reference: GCCOV-502a-NN
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Coronavirus Ag Rapid Test Cassette (Swab)

GCCOV-502a-NA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-NAHGUY
Basic UDI-DI: B-GCCOV-502a-NAHGUY
Reference: GCCOV-502a-NA
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H7

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H78P
Basic UDI-DI: B-GCCOV-502a-H78P
Reference: GCCOV-502a-H7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H5

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H58K
Basic UDI-DI: B-GCCOV-502a-H58K
Reference: GCCOV-502a-H5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H3

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H38F
Basic UDI-DI: B-GCCOV-502a-H38F
Reference: GCCOV-502a-H3
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H2

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H28D
Basic UDI-DI: B-GCCOV-502a-H28D
Reference: GCCOV-502a-H2
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H20

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H20GH
Basic UDI-DI: B-GCCOV-502a-H20GH
Reference: GCCOV-502a-H20
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H1

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H18B
Basic UDI-DI: B-GCCOV-502a-H18B
Reference: GCCOV-502a-H1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H15

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H15GQ
Basic UDI-DI: B-GCCOV-502a-H15GQ
Reference: GCCOV-502a-H15
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H10

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H10GE
Basic UDI-DI: B-GCCOV-502a-H10GE
Reference: GCCOV-502a-H10
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details