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AutoChem GLU

AutoChem series instrument

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253004661
Basic UDI-DI: 69422530000049NU
Reference: 360104GLU000S
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem UA

AutoChem series instrument

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253002469
Basic UDI-DI: 69422530000026NG
Reference: 360102UA0000S
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

Urea

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153007361
Basic UDI-DI: 6438153BU00148C2
Reference: 981954
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 18:02

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HDL-Cholesterol

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153007330
Basic UDI-DI: 6438153BU00133BM
Reference: 981955
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 18:02

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Bilirubin Direct

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153004391
Basic UDI-DI: 6438153BU00171BV
Reference: 981909
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 18:02

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HbA1c

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153002397
Basic UDI-DI: 6438153BU00022BB
Reference: 981947
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 18:02

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Porphyrins HPLC

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598826014
Basic UDI-DI: B-04050598826014
Reference: KC2601
EMDN: W01010229
EMDN description: TOTAL PORPHYRINE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

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OGTTest Solução Oral de Glucose

IVD Class ANot specifiedNo longer on the marketDirect markingSingle use

Manufacturer: ESTERIPLAS- PRODUTOS PARA A AREA DA SAUDE, LDA
Manufacturer SRN: PT-MF-000033228
UDI-DI: 05608384015389
Basic UDI-DI: 5608384OGTTestK9
Reference: SG.OGTT201.050
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Portugal
Authorised representative: -
Last updated: 31.07.2026 11:44

Manufacturer products View details

OGTTest Solução Oral de Glucose

IVD Class ANot specifiedNo longer on the marketDirect markingSingle use

Manufacturer: ESTERIPLAS- PRODUTOS PARA A AREA DA SAUDE, LDA
Manufacturer SRN: PT-MF-000033228
UDI-DI: 05608384015372
Basic UDI-DI: 5608384OGTTestK9
Reference: SG.OGTT200.050
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Portugal
Authorised representative: -
Last updated: 31.07.2026 11:33

Manufacturer products View details

Fructose Test Reagent 1

FRUCTO

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967001712
Basic UDI-DI: 5411967FRUCTO14K
Reference: FRUCTO_1
EMDN: W01010211
EMDN description: FRUCTOSE
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:59

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HSi Hemolysis & Wash Solution-(L)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Tosoh Europe N.V.
Manufacturer SRN: BE-MF-000000210
UDI-DI: 04562185380019
Basic UDI-DI: 543000049500018431LRB
Reference: 018431L
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:57

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Fructose Test

FRUCTO

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967000289
Basic UDI-DI: 5411967FRUCTO14K
Reference: FRUCTO
EMDN: W01010211
EMDN description: FRUCTOSE
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:51

Manufacturer products View details

Glucose

HBL04(A,M)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100578
Basic UDI-DI: 54040351HBL046P
Reference: HBL04M
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:50

Manufacturer products View details

Glucose

HBL04(A,M)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100561
Basic UDI-DI: 54040351HBL046P
Reference: HBL04
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

Manufacturer products View details

HbA1c ΔΙΑΛΥΜΑ ΑΙΜΟΛΥΣΗΣ 1x100 ml

DILUTING SOLUTION

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Biotechnological Applications Ltd
Manufacturer SRN: GR-MF-000033000
UDI-DI: 05213003193043
Basic UDI-DI: 521300319DILUENV9
Reference: 001781
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:46

Manufacturer products View details

HDL-Cholesterol

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309175604
Basic UDI-DI: 5204309000027NW
Reference: 1517-0240
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:25

Manufacturer products View details

ALBUMIN

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309175581
Basic UDI-DI: 5204309000005NL
Reference: 1517-0190
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:25

Manufacturer products View details

URINARY-CSF PROTEIN

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309175574
Basic UDI-DI: 5204309000048P6
Reference: 1517-0189
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:25

Manufacturer products View details

TOTAL PROTEIN

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309175567
Basic UDI-DI: 5204309000042NS
Reference: 1517-0180
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:25

Manufacturer products View details

TOTAL BILIRUBIN

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309175543
Basic UDI-DI: 5204309000041NQ
Reference: 1517-0148
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:25

Manufacturer products View details