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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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276 device results listed.

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NT-proBNP Fast Test Kit (Immunofluorescence Assay)

NT-proBNP Fast Test Kit (Immunofluorescence Assay)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792614
Basic UDI-DI: 695441470201GQ
Reference: IF5002
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Fast Test Kit (Immunofluorescence Assay)

Cardiac Troponin I Fast Test Kit (Immunofluorescence Assay)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792607
Basic UDI-DI: 695441470200GN
Reference: IF5001
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Tg Fast Test Kit (Immunofluorescence Assay)

Anti-Tg Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792218
Basic UDI-DI: B-06954414792218
Reference: /
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TPO Fast Test Kit (Immunofluorescence Assay)

Anti-TPO Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792201
Basic UDI-DI: B-06954414792201
Reference: /
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Osteocalcin Fast Test Kit (Immunofluorescence Assay)

Osteocalcin Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792195
Basic UDI-DI: B-06954414792195
Reference: /
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE Fast Test Kit (Immunofluorescence Assay)

Total IgE Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792164
Basic UDI-DI: B-06954414792164
Reference: /
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol Fast Test Kit (Immunofluorescence Assay）

Cortisol Fast Test Kit (Immunofluorescence Assay）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792034
Basic UDI-DI: B-06954414792034
Reference: /
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit

Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751871
Basic UDI-DI: 695441479706KS
Reference: RT6005
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit

Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751864
Basic UDI-DI: 695441479706KS
Reference: RT6005
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso HPV Real-time PCR Kit

Akso HPV Real-time PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751192
Basic UDI-DI: 695441479704KN
Reference: RT6003
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso HPV Real-time PCR Kit

Akso HPV Real-time PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751185
Basic UDI-DI: 695441479704KN
Reference: RT6003
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso HPV Real-time PCR Kit

Akso HPV Real-time PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751178
Basic UDI-DI: 695441479704KN
Reference: RT6003
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso HPV Real-time PCR Kit

Akso HPV Real-time PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751161
Basic UDI-DI: 695441479704KN
Reference: RT6003
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso HPV Real-time PCR Kit

Akso HPV Real-time PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751154
Basic UDI-DI: 695441479704KN
Reference: RT6003
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso HPV Real-time PCR Kit

Akso HPV Real-time PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751147
Basic UDI-DI: 695441479704KN
Reference: RT6003
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Rapid Test

Influenza A/B Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414750805
Basic UDI-DI: 695441474622JG
Reference: CG2059
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Progesterone (CLIA)

MAGICL Progesterone (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414750782
Basic UDI-DI: 695441479819L8
Reference: CLIA3022A
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Progesterone (CLIA)

MAGICL Progesterone (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414750775
Basic UDI-DI: 695441479819L8
Reference: CLIA3022A
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Progesterone (CLIA)

MAGICL Progesterone (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414750768
Basic UDI-DI: 695441479819L8
Reference: CLIA3022A
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Progesterone (CLIA)

MAGICL Progesterone (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414750751
Basic UDI-DI: 695441479819L8
Reference: CLIA3022A
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details