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IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M Reagent

IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221218
Basic UDI-DI: 150995901447470LE
Reference: 447470
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221195
Basic UDI-DI: 150995901447610L6
Reference: 447610
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

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IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent

IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221171
Basic UDI-DI: 150995901447450L8
Reference: 447450
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

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IMMAGE Immunochemistry Systems TRF Transferrin Reagent

IMMAGE Immunochemistry Systems TRF Transferrin Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180171
Basic UDI-DI: 150995901447630LC
Reference: 447630
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

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IMMAGE Immunochemistry Systems MA Microalbumin Reagent

IMMAGE Immunochemistry Systems MA Microalbumin Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180164
Basic UDI-DI: 150995901447690LW
Reference: 447690
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

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N Latex FLC kappa

IVDR_27_MAR EB_C_PROF_REAG_N_La_FLC_2

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768031410
Basic UDI-DI: 0405686902230V4
Reference: 10482437
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

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Dimension Vista Transferrin Flex reagent cartridge

IVDR_67_MAR EB_B_KIT_V_TRF

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006258
Basic UDI-DI: 0405686900929W8
Reference: 10445910
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

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Dimension Vista Prealbumin Flex reagent cartridge

IVDR_67_MAR EB_B_KIT_V_PREALB

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006210
Basic UDI-DI: 0405686900921VQ
Reference: 10445906
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

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Dimension Vista Microalbumin Flex reagent cartridge

IVDR_67_MAR EB_C_KIT_V_MALB

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006203
Basic UDI-DI: 0405686900920VN
Reference: 10445905
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

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Dimension Vista Immunoglobulin M Flex reagent cartridge

IVDR_67_MAR EB_C_KIT_V_IGM

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006197
Basic UDI-DI: 0405686900919W5
Reference: 10445904
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

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Dimension Vista Immunoglobulin G Flex reagent cartridge

IVDR_67_MAR EB_C_KIT_V_IGG

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006180
Basic UDI-DI: 0405686900918W3
Reference: 10445903
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

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Dimension Vista Haptoglobin Flex reagent cartridge

IVDR_67_MAR EB_B_KIT_V_HAPT

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006111
Basic UDI-DI: 0405686900913VR
Reference: 10445896
EMDN: W0102010302
EMDN description: HAPTOGLOBIN
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

Manufacturer products View details

Calprotectin

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147180720
Basic UDI-DI: B-86060147180720
Reference: N1811CALP
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 30.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin/Haptoglobin Complex

Hemoglobin/Haptoglobin Complex

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147127046
Basic UDI-DI: B-86060147127046
Reference: N1812HBHP
EMDN: W0102010302
EMDN description: HAPTOGLOBIN
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 30.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin/Haptoglobin Complex

Hemoglobin/Haptoglobin Complex

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313277148
Basic UDI-DI: B-86060313277148
Reference: C1812HBHP
EMDN: W0102010302
EMDN description: HAPTOGLOBIN
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 30.07.2026 02:29

Manufacturer products Authorised representative products Authorised representative actors View details

BCA-225 [Cu-18]

ACI3241B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627024831
Basic UDI-DI: B-00847627024831
Reference: ACI3241B
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

BCA-225 [Cu-18]

ACI3241A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627024824
Basic UDI-DI: B-00847627024824
Reference: ACI3241A
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Latvia
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbuminuria (MALB) Test Kit (Immunoturbidimetric)

R1:70ml×6 R2:42ml×2（795）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306054
Basic UDI-DI: B-06936895306054
Reference: R1:70ml×6 R2:42ml×2（795）
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbuminuria (MALB) Test Kit (Immunoturbidimetric)

R1:25mL×4 R2:5mL×4（796）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306047
Basic UDI-DI: B-06936895306047
Reference: R1:25mL×4 R2:5mL×4（796）
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147143336
Basic UDI-DI: B-86060147143336
Reference: C1811CALP
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 29.07.2026 09:18

Manufacturer products Authorised representative products Authorised representative actors View details