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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TREN

Last updated

23.09.2026 12:14

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Successful

Device

3541597

Actor

47811

Certificate

3399

Active filter:Manufacturer SRN:FI-MF-000001479

214 device results listed.

Page 8 / 11

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D-Dimer

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 productsView details
sTfR Calibration Set

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
Manufacturer productsView details
INDIKO

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 productsView 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 productsView 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 productsView 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 productsView 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
Manufacturer productsView details
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
Manufacturer productsView details
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 productsView 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
Manufacturer productsView details
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 productsView 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 productsView 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 productsView 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 productsView 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 productsView 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 productsView 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 productsView 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 productsView 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 productsView 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 productsView details