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214 device results listed.

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D-Dimer

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153000744
Basic UDI-DI: 6438153BU00062BP
Reference: 981946
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details

sTfR Calibration Set

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

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153000713
Basic UDI-DI: 6438153BU00118BR
Reference: 981865
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

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INDIKO

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 06438153001119
Basic UDI-DI: 6438153BU00187CC
Reference: 98630000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Indiko Ultra

INDIKO

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 06438153840503
Basic UDI-DI: 6438153BU02006BT
Reference: 98730000-0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Parallel Bypass, TCA Siemens Centaur XP

Buffer, TCA

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 06438153000082
Basic UDI-DI: 6438153BU0001138F
Reference: 952246
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Grip Carrier

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153006579
Basic UDI-DI: 6438153BU00197CF
Reference: 952332
EMDN: W02060185
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

Manufacturer products View details

Reference Electrode Solution

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153803147
Basic UDI-DI: 6438153BU00144BS
Reference: 980314
EMDN: W0101070302
EMDN description: ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

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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: 16438153817694
Basic UDI-DI: 6438153BU00157C3
Reference: 981769
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

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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: 16438153817717
Basic UDI-DI: 6438153BU00160BQ
Reference: 981771
EMDN: W01010110
EMDN description: ASPARTATE AMINO-TRANSFERASE
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

Manufacturer products View details

Gamma-GT (IFCC)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817786
Basic UDI-DI: 6438153BU00161BS
Reference: 981778
EMDN: W01010116
EMDN description: GAMMA GLUTAMYLTRANSFERASE
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

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CK (IFCC)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818295
Basic UDI-DI: 6438153BU00159C7
Reference: 981829
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

Manufacturer products View details

Alkaline Phosphatase (IFCC) Plus

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818332
Basic UDI-DI: 6438153BU00156BZ
Reference: 981833
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

Manufacturer products View details

CK-MB

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818370
Basic UDI-DI: 6438153BU00052BL
Reference: 981837
EMDN: W01010114
EMDN description: CREATINE KINASE - MB ACTIVITY (CC)
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

Manufacturer products View details

Bicarbonate

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818899
Basic UDI-DI: 6438153BU00175C5
Reference: 981889
EMDN: W01010302
EMDN description: BICARBONATE
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

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: 16438153818912
Basic UDI-DI: 6438153BU00183C4
Reference: 981891
EMDN: W01010307
EMDN description: PHOSPHATE INORGANIC / PHOSPHORUS
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

Manufacturer products View details

Creatinine (Enzymatic)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818967
Basic UDI-DI: 6438153BU00130BF
Reference: 981896
EMDN: W01010207
EMDN description: CREATININE
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

Manufacturer products View details

Storage Cap

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

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153840487
Basic UDI-DI: 6438153BU00196CD
Reference: 952374
EMDN: W02060185
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 13:21

Manufacturer products View details

Indiko Ultra XL ISE

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 06438153840572
Basic UDI-DI: 6438153BU02006BT
Reference: 98741000-0
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:39

Manufacturer products View details

Indiko Ultra XL

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 06438153840565
Basic UDI-DI: 6438153BU02006BT
Reference: 98740000-0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:39

Manufacturer products View details

Indiko Ultra ISE

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 06438153840510
Basic UDI-DI: 6438153BU02006BT
Reference: 98731000-0
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:39

Manufacturer products View details