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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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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
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
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
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
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
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
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
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
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
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
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
D-MUR-24E3W

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
D-MME-14ETX

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
D-MLR-19EYG

Lower Respiratory Pathogens Multiplex Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hysen Biotech.Inc
Manufacturer SRN
KR-MF-000048224
UDI-DI
D-MLR-19EYG
Basic UDI-DI
B-MLR-19EYG
Reference
MLR-19E
EMDN
W0105070503
EMDN description
RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Spain
Authorised representative
Medunion S.L.
Last updated
17.07.2026 05:09
Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test

Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN
CN-MF-000010710
UDI-DI
D-IRTB-R555H2
Basic UDI-DI
B-IRTB-R555H2
Reference
IRTB-R555
EMDN
W0105070399
EMDN description
MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country
Austria
Authorised representative
VidaQuick Biotech S.L.
Last updated
17.07.2026 05:04
Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test

Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN
CN-MF-000010710
UDI-DI
D-IRTA-R555GM
Basic UDI-DI
B-IRTA-R555GM
Reference
IRTA-R555
EMDN
W0105070399
EMDN description
MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country
Austria
Authorised representative
VidaQuick Biotech S.L.
Last updated
17.07.2026 05:04
Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test

Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN
CN-MF-000010710
UDI-DI
D-IRTA-R545GJ
Basic UDI-DI
B-IRTA-R545GJ
Reference
IRTA-R545
EMDN
W0105070399
EMDN description
MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country
Austria
Authorised representative
VidaQuick Biotech S.L.
Last updated
17.07.2026 05:04
Norovirus and Rotavirus Combo Rapid Test

Norovirus and Rotavirus Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN
CN-MF-000010710
UDI-DI
D-INRC-625KJ
Basic UDI-DI
B-INRC-625KJ
Reference
INRC-625
EMDN
W0105070599
EMDN description
MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country
Austria
Authorised representative
VidaQuick Biotech S.L.
Last updated
17.07.2026 05:03
D-DBP01UK

Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hysen Biotech.Inc
Manufacturer SRN
KR-MF-000048224
UDI-DI
D-DBP01UK
Basic UDI-DI
B-DBP01UK
Reference
DBP01
EMDN
W0105070502
EMDN description
OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country
Spain
Authorised representative
Medunion S.L.
Last updated
17.07.2026 04:58
D-697994388Nc010ZABW

Shigella/Entamoeba histolytica Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN
CN-MF-000053775
UDI-DI
D-697994388Nc010ZABW
Basic UDI-DI
B-697994388Nc010ZABW
Reference
Nc010
EMDN
W0105070201
EMDN description
GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS
First on market country
Germany
Authorised representative
Crealkraft GmbH
Last updated
17.07.2026 04:26