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214 device results listed.

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Glucose (GOD-POD)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153813795
Basic UDI-DI: 6438153BU00059C2
Reference: 981379
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

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Gamma-GT (IFCC)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153813771
Basic UDI-DI: 6438153BU00161BS
Reference: 981377
EMDN: W01010116
EMDN description: GAMMA GLUTAMYLTRANSFERASE
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

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AST / GOT (IFCC)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153813634
Basic UDI-DI: 6438153BU00160BQ
Reference: 981363
EMDN: W01010110
EMDN description: ASPARTATE AMINO-TRANSFERASE
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

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ALT / GPT (IFCC)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153813610
Basic UDI-DI: 6438153BU00157C3
Reference: 981361
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

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Triglycerides

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153813016
Basic UDI-DI: 6438153BU00147BY
Reference: 981301
EMDN: W01010231
EMDN description: TRIGLYCERIDES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

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Iron

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153812361
Basic UDI-DI: 6438153BU00134BP
Reference: 981236
EMDN: W01010216
EMDN description: IRON (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

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SpeciCal

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153809972
Basic UDI-DI: 6438153BU00167C6
Reference: 980997
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

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Reference Electrode Kit

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153808456
Basic UDI-DI: 6438153BU00145BU
Reference: 980845
EMDN: W0101070301
EMDN description: REFERENCE ELECTRODES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

Manufacturer products View details

Phosphorus

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153020032
Basic UDI-DI: 6438153BU02002BK
Reference: 981951
EMDN: W01010307
EMDN description: PHOSPHATE INORGANIC / PHOSPHORUS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

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16438153007774

Cholesterol

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153007774
Basic UDI-DI: 6438153BU00200BB
Reference: 981957
EMDN: W01010205
EMDN description: CHOLESTEROL
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

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Bilirubin Total (DCA)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153007347
Basic UDI-DI: 6438153BU00126BQ
Reference: 981952
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

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Amylase (IFCC)

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153005220
Basic UDI-DI: 6438153BU00061BM
Reference: 981950
EMDN: W01010107
EMDN description: AMYLASE - TOTAL
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

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LDL-Cholesterol

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153004766
Basic UDI-DI: 6438153BU00140BJ
Reference: 981956
EMDN: W01010221
EMDN description: LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details

Cholinesterase

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153004575
Basic UDI-DI: 6438153BU00177C9
Reference: 981910
EMDN: W01010111
EMDN description: CHOLINESTERASE
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details

TCA Storage Cap

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153004520
Basic UDI-DI: 6438153BU00196CD
Reference: 952314
EMDN: W02060185
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details

Ferritin

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153004094
Basic UDI-DI: 6438153BU00125BN
Reference: 981949
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

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INDIKO ISE Calibrator 1

ISE Calibrator 1

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153004070
Basic UDI-DI: 6438153BU00135BR
Reference: 984032
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details

Disposable Aliquoter Tips

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153003400
Basic UDI-DI: 6438153BU00195CB
Reference: 952298
EMDN: W02060185
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details

D-Dimer Control High

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153003240
Basic UDI-DI: 6438153BU00066BX
Reference: 981869
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details

D-Dimer Control

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153003233
Basic UDI-DI: 6438153BU00064BT
Reference: 981868
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details