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276 device results listed.

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MAGICL Myo (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798029
Basic UDI-DI: B-06954414798029
Reference: /
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL hs-cTnI (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798012
Basic UDI-DI: B-06954414798012
Reference: /
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Getein

MAGICL CK-MB (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798005
Basic UDI-DI: B-06954414798005
Reference: /
EMDN: W01010115
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

H-FABP 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: 06954414792997
Basic UDI-DI: 695441470212GV
Reference: IF5014
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB 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: 06954414792942
Basic UDI-DI: 695441470215H3
Reference: IF5018
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

IL-6 Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792904
Basic UDI-DI: 695441470272HF
Reference: IF5088
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792867
Basic UDI-DI: 695441470261HA
Reference: IF5073
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792782
Basic UDI-DI: B-06954414792782
Reference: /
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

SAA Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792775
Basic UDI-DI: 695441470235H9
Reference: IF5044
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-VD Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792768
Basic UDI-DI: 695441470229HE
Reference: IF5031
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

TSH Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792737
Basic UDI-DI: 695441470224H4
Reference: IF5024
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

T4 Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792720
Basic UDI-DI: 695441470222GY
Reference: IF5023
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

T3 Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792713
Basic UDI-DI: 695441470221GW
Reference: IF5022
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c 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: 06954414792690
Basic UDI-DI: 695441470214GZ
Reference: IF5017
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

β2-MG Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792683
Basic UDI-DI: 695441470211GT
Reference: IF5011
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

CysC Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792676
Basic UDI-DI: 695441470210GR
Reference: IF5008
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

mAlb Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792669
Basic UDI-DI: 695441470209H8
Reference: IF5009
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

NGAL Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792652
Basic UDI-DI: 695441470208H6
Reference: IF5010
EMDN: W0102060207
EMDN description: NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

PCT 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: 06954414792645
Basic UDI-DI: 695441470207H4
Reference: IF5007
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

hs-CRP+CRP 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: 06954414792621
Basic UDI-DI: 695441470202GS
Reference: IF5003
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
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