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IMMULITE 2000 Total Testosterone

IVDR_67_LLB_DUB-C_B_REAG_KIT_Total Testosterone

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962214
Basic UDI-DI: 0405686901414V9
Reference: 10381190
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Progesterone

IVDR_67_LLB_DUB-C_B_KIT_Progestrne

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961989
Basic UDI-DI: 0405686901401UY
Reference: 10381170
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Prolactin

IVDR_67_LLB_DUB-C_B_KIT_Prolctn

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961934
Basic UDI-DI: 0405686901402V2
Reference: 10381200
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

N Latex BTP

IVDR_27_MAR EB_B_KIT _N_La_BTP

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768037634
Basic UDI-DI: 0405686900879WJ
Reference: 10709757
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

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N Latex Cystatin C

IVDR_27_MAR EB_C_KIT _Na_La_CYS_C

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768037351
Basic UDI-DI: 0405686900986WL
Reference: 10709554
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

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N a1-Microglobulin Kit

IVDR_27_MAR EB_B_KIT_N_a1-MIC_Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768012938
Basic UDI-DI: 0405686900892WA
Reference: 10446619
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

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N Antiserum to Human Fibronectin

IVDR_27_MAR EB_B_REAG_N_AS_FibNec

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768011498
Basic UDI-DI: 0405686900944W4
Reference: 10446462
EMDN: W0102019005
EMDN description: FIBRONECTIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

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N Antiserum to Human a1-acid Glycoprotein

IVDR_27_MAR EB_B_REAG_N_AS_a1-aG

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768009877
Basic UDI-DI: 0405686900952W3
Reference: 10446306
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

Manufacturer products View details

α₂-Macroglobulin Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-a2-MG601AB
Basic UDI-DI: B-a2-MG601AB
Reference: α2-MG6011Y, α2-MG6012Y, α2-MG6013Y, α2-MG6014Y, α2-MG6015Y, α2-MG6011N, α2-MG6012N, α2-MG6013N, α2-MG6014N, α2-MG6015N
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

α₁-Microglobulin Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-a1-MG6019S
Basic UDI-DI: B-a1-MG6019S
Reference: α1-MG6011Y, α1-MG6012Y, α1-MG6013Y, α1-MG6014Y, α1-MG6015Y, α1-MG6011N, α1-MG6012N, α1-MG6013N, α1-MG6014N, α1-MG6015N
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Beta Amyloid 40 Test Kit (FIA)

VID144

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID144EZ
Basic UDI-DI: B-VID144EZ
Reference: VID144-07-011
EMDN: W0102019013
EMDN description: BETA-AMYLOID (1-40)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Myxovirus Resistance Protein A Test Kit (FIA)

VID137

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID137F4
Basic UDI-DI: B-VID137F4
Reference: VID137-01-011
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Test Kit (FIA)

VID04

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID042P
Basic UDI-DI: B-VID042P
Reference: VID04-01-011
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Cystatin C Test Kit (FIA)

VID03

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID032M
Basic UDI-DI: B-VID032M
Reference: VID03-02-011
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-6149

Calprotectin Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-6149
Basic UDI-DI: B-TD-HNKX-CED-6149
Reference: /
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-3446

Placental Alpha-1-microglobulin Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-3446
Basic UDI-DI: B-TD-HNKX-CED-3446
Reference: /
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-3344

Fetal Fibronectin Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-3344
Basic UDI-DI: B-TD-HNKX-CED-3344
Reference: /
EMDN: W0102019005
EMDN description: FIBRONECTIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-SL80-LPVG

Lipoprotein electrophoresis kit 80 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-SL80-LPVG
Basic UDI-DI: B-SL80-LPVG
Reference: SL-80-LP
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 06:30

Manufacturer products View details

D-SL-100-UPNY

Urinary protein electrophoresis kit 100 tests 4 samples

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-SL-100-UPNY
Basic UDI-DI: B-SL-100-UPNY
Reference: SL-100-SP
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 06:30

Manufacturer products View details

NF-light ELISA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: UmanDiagnostics 5566982418
Manufacturer SRN: SE-MF-000031407
UDI-DI: D-SE-MF-0000314075B
Basic UDI-DI: B-SE-MF-0000314075B
Reference: 10-7001
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 15.07.2026 05:57

Manufacturer products View details