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

R1: 1x45ml, R2: 1x15ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239403
Basic UDI-DI: B-06942202239403
Reference: 3004595
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

APOLIPOPROTEIN A1 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）

R1: 1x50ml, R2: 1x10ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794589118
Basic UDI-DI: B-06925794589118
Reference: 3004591
EMDN: W0102010401
EMDN description: APOLIPOPROTEIN A I
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Complement C4

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819322
Basic UDI-DI: 6438153BU00179CD
Reference: 981932
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Complement C3

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819315
Basic UDI-DI: 6438153BU00178CB
Reference: 981931
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Apolipoprotein B

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819308
Basic UDI-DI: 6438153BU00174C3
Reference: 981930
EMDN: W0102010403
EMDN description: APOLIPOPROTEIN B
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 22:00

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Lactoferrin Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OLF-ACO6074W
Basic UDI-DI: B-OLF-ACO6074W
Reference: OLF-ACO607
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 20:47

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Calprotectin and Lactoferrin Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OIBD-ACO627YX
Basic UDI-DI: B-OIBD-ACO627YX
Reference: OIBD-ACO627
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 20:47

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Calprotectin Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OCAL-ACO607XC
Basic UDI-DI: B-OCAL-ACO607XC
Reference: OCAL-ACO607
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: France
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 20:46

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Ferritin Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-FER-402MQ
Basic UDI-DI: B-ACO-FER-402MQ
Reference: ACO-FER-402
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Finland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

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ASO Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-ASO-402PQ
Basic UDI-DI: B-ACO-ASO-402PQ
Reference: ACO-ASO-402
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

alfa-1- ANTITRIPSINA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155009037
Basic UDI-DI: B-18430155009037
Reference: 993802
EMDN: W0102019002
EMDN description: A1-ANTITRYPSIN (PROTEASE INHIBITOR)
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:48

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APOLIPOPROTEÍNA B

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155009006
Basic UDI-DI: B-18430155009006
Reference: 993406
EMDN: W0102010403
EMDN description: APOLIPOPROTEIN B
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:48

Manufacturer products View details

APOLIPOPROTEÍNA A1

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155008993
Basic UDI-DI: B-18430155008993
Reference: 993402
EMDN: W0102010401
EMDN description: APOLIPOPROTEIN A I
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:48

Manufacturer products View details

alfa-1 GLUCOPROTEÍNA ÁCIDA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155008894
Basic UDI-DI: B-18430155008894
Reference: 994005
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:48

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COMPLEMENTO C4

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155008887
Basic UDI-DI: B-18430155008887
Reference: 993669
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:48

Manufacturer products View details

COMPLEMENTO C3

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155008870
Basic UDI-DI: B-18430155008870
Reference: 993250
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:48

Manufacturer products View details

MICROALBÚMINA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155007804
Basic UDI-DI: B-18430155007804
Reference: 993800
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:47

Manufacturer products View details

TRANSFERRINA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155003028
Basic UDI-DI: B-18430155003028
Reference: 990604
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:46

Manufacturer products View details

09120122928059

FOX Food Explorer

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122928059
Basic UDI-DI: B-09120122928059
Reference: 80-5001-01
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Italy
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

Membranous Nephropathy Detection Kit

24 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangxi CellGene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055358
UDI-DI: 06977846952395
Basic UDI-DI: B-06977846952395
Reference: E021700103
EMDN: W0102010199
EMDN description: IMMUNOGLOBULINS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details