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276 device results listed.

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Cortisol 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: 06954414733341
Basic UDI-DI: 695441479203JT
Reference: IF5110
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Syphilis (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414732504
Basic UDI-DI: 695441479904KY
Reference: CLIA3062A
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Syphilis (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414732290
Basic UDI-DI: 695441479904KY
Reference: CLIA3062A
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL HA (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414731439
Basic UDI-DI: 695441479851L4
Reference: CLIA3070A
EMDN: W0102120103
EMDN description: HYALURONIC ACID
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL HA (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414730982
Basic UDI-DI: 695441479851L4
Reference: CLIA3070A
EMDN: W0102120103
EMDN description: HYALURONIC ACID
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

SAA/CRP 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: 06954414729955
Basic UDI-DI: 695441470274HK
Reference: IF5090
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL CA125 (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414729177
Basic UDI-DI: 695441479828L9
Reference: CLIA3036A
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL CA125 (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414729122
Basic UDI-DI: 695441479828L9
Reference: CLIA3036A
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL IL-6 (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414729030
Basic UDI-DI: 695441479838LC
Reference: CLIA3046A
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 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL IL-6 (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414729023
Basic UDI-DI: 695441479838LC
Reference: CLIA3046A
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 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL TSH (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414728910
Basic UDI-DI: 695441479810KN
Reference: CLIA3012A
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06954414728613
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 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Cortisol (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414728422
Basic UDI-DI: 695441479813KU
Reference: CLIA3016A
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL TSH (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414728279
Basic UDI-DI: 695441479810KN
Reference: CLIA3012A
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06954414728170
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 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Cortisol (CLIA)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414728033
Basic UDI-DI: 695441479813KU
Reference: CLIA3016A
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

06954414727159

H. pylori Antigen Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414727159
Basic UDI-DI: 695441470237HD
Reference: IF1047
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

ASO Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414724912
Basic UDI-DI: 695441470264HG
Reference: IF2076
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Belgium
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

ASO Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414724899
Basic UDI-DI: 695441470264HG
Reference: IF1076
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 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: 06954414724325
Basic UDI-DI: 695441470258HM
Reference: IF5070
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details