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

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

GEFTH-T625a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEFTH-T625aOGT8
Basic UDI-DI: B-GEFTH-T625aOGT8
Reference: GEFTH-T625a
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

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

GEFTH-T625a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFTH-T625aHGSK
Basic UDI-DI: B-GEFTH-T625aHGSK
Reference: GEFTH-T625a
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Antigen Multiple Test Kit

C2134

IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815347
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CRF-01
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815354
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CRF-02
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815361
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CRF-03
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815378
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CRF-04
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815385
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CR-01
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815392
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CR-02
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815408
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CR-03
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815415
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CR-04
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815422
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CF-01
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815439
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CF-02
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815446
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CF-03
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815453
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-CF-04
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815460
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-RF-01
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815477
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-RF-02
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815484
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-RF-03
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

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IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: Atlas Link Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021058
UDI-DI: 06970725815491
Basic UDI-DI: 697072581D2SRF25M32P15CT3
Reference: C2134-RF-04
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): ALK-IVDR-R4M-Nasal-TDs-32 · Rev. A1
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Respiratory Pathogens Multiplex Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: D-MUR-24E3W
Basic UDI-DI: B-MUR-24E3W
Reference: MUR-24E
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

Meningitis/Encephalitis (ME) Pathogens Multiplex Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: D-MME-14ETX
Basic UDI-DI: B-MME-14ETX
Reference: MME-14E
EMDN: W0105070505
EMDN description: MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details