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IMMULITE 2000 FSH

IVDR_67_LLB_DUB-C_B_REAG_KIT_follicle stimulating hor

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961507
Basic UDI-DI: 0405686901382VM
Reference: 10381201
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 06.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

COMPLEMENTO C4

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155012013
Basic UDI-DI: B-18430155012013
Reference: 951547
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 01:31

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COMPLEMENTO C3

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155012006
Basic UDI-DI: B-18430155012006
Reference: 951546
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 01:31

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LİPOPROTEİN A

LIPOPROTEIN A

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812534857
Basic UDI-DI: B-08681812534857
Reference: LN081
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Türkiye
Authorised representative: -
Last updated: 06.08.2026 01:11

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LİPOPROTEİN A

LIPOPROTEIN A

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812534840
Basic UDI-DI: B-08681812534840
Reference: LN080
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Türkiye
Authorised representative: -
Last updated: 06.08.2026 01:11

Manufacturer products View details

AESKUBLOTS® Food Intolerance FIFTY-FIVE

AESKUBLOTS® Food Intolerance

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289512176
Basic UDI-DI: B-04250289512176
Reference: 431455.BULK120
EMDN: W0102010106
EMDN description: IMMUNOGLOBULIN G SUBCLASS REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:13

Manufacturer products View details

IGG IP

IIGG-5025

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700822523
Basic UDI-DI: B-03701700822523
Reference: IIGG-5025
EMDN: W0102010106
EMDN description: IMMUNOGLOBULIN G SUBCLASS REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 17:10

Manufacturer products View details

Immunoglobulin G

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819377
Basic UDI-DI: 6438153BU00109BQ
Reference: 981937
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 16:15

Manufacturer products View details

Immunoglobulin M

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819384
Basic UDI-DI: 6438153BU00110B9
Reference: 981938
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 16:15

Manufacturer products View details

Immunoglobulin A

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819360
Basic UDI-DI: 6438153BU00108BN
Reference: 981936
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Finland
Authorised representative: -
Last updated: 05.08.2026 16:15

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β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

Calibration sample: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261589
Basic UDI-DI: B-06942202261589
Reference: 232021502013
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 14:32

Manufacturer products Authorised representative products Authorised representative actors View details

LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593757
Basic UDI-DI: B-06925794593757
Reference: 3021646
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

Apolipoprotein C3 Reagent Kit (Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL,Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794576927
Basic UDI-DI: B-06925794576927
Reference: 3019823
EMDN: W0102010499
EMDN description: LIPOPROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

Complement C1q Reagent Kit (Immunoturbidimetric Assay)

R1：1x40mL, R2：1x10mL,Calibration sample: 1x1mL,Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794574930
Basic UDI-DI: B-06925794574930
Reference: 3019820
EMDN: W0102010201
EMDN description: COMPLEMENT COMPONENT C1Q
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 05.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

Complement C1q Reagent Kit (Immunoturbidimetric Assay)

R1：1x40mL, R2：1x10mL,Calibration sample: 1x1mL,Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794574923
Basic UDI-DI: B-06925794574923
Reference: 3019788
EMDN: W0102010201
EMDN description: COMPLEMENT COMPONENT C1Q
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 05.08.2026 14:15

Manufacturer products Authorised representative products Authorised representative actors View details

A-400 COMPLEMENT C3

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514674114
Basic UDI-DI: B-05907514674114
Reference: 7-411
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Poland
Authorised representative: -
Last updated: 05.08.2026 14:00

Manufacturer products View details

A-400 TRANSFERRIN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514674107
Basic UDI-DI: B-05907514674107
Reference: 7-410
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Poland
Authorised representative: -
Last updated: 05.08.2026 14:00

Manufacturer products View details

CORMAY LIPOPROTEIN (a)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514663026
Basic UDI-DI: B-05907514663026
Reference: 6-302
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Poland
Authorised representative: -
Last updated: 05.08.2026 14:00

Manufacturer products View details

Albumin urine & CSF

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168017558
Basic UDI-DI: B-05415168017558
Reference: MATUR-B00/CDC
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Belgium
Authorised representative: -
Last updated: 05.08.2026 13:47

Manufacturer products View details

Albumin urine & CSF

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168017565
Basic UDI-DI: B-05415168017565
Reference: MATUR-H00/CDC
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Belgium
Authorised representative: -
Last updated: 05.08.2026 13:47

Manufacturer products View details