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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Last updated

17.07.2026 09:39

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Successful

Device

2837068

Actor

47414

Certificate

3106

Active filter:Manufacturer SRN:CN-MF-000011840

607 device results listed.

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CSVXML
D-6-136FM

Multiple compound quality control products for urine assay

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-136FM
Basic UDI-DI
B-6-136FM
Reference
"REF: USCA00000755-USCA00000763"
EMDN
W01021521
EMDN description
MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-135FK

Procalcitonin (PCT)Test Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-135FK
Basic UDI-DI
B-6-135FK
Reference
"REF: USCA00000750, USCA00000753 USCA00000751, USCA00000752 USCA00000754, USCA00000782"
EMDN
W0102069013
EMDN description
PROCALCITONIN
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-134FH

Serum amyloid A(SAA)Test Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-134FH
Basic UDI-DI
B-6-134FH
Reference
"REF: USCA00000745, USCA00000748 USCA00000746 USCA00000747, USCA00000749"
EMDN
W0102019099
EMDN description
SPECIFIC PROTEINS - OTHER
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-132FD

Creatine Kinase MB Isoenzymes Reagent Kit (Immunosuppressive method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-132FD
Basic UDI-DI
B-6-132FD
Reference
"REF: U84685040M U84689060M, U84622060M U84685020M"
EMDN
W01010115
EMDN description
CREATINE KINASE ISOENZYMES
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-131FB

Glucose Reagent Kit（Hexokinase Method）

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-131FB
Basic UDI-DI
B-6-131FB
Reference
"REF: U83885040M U83889060M, U83822060M U83885020M"
EMDN
W01010213
EMDN description
GLUCOSE
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-133FF

Cardiac troponin I (cTnI ) Test Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-133FF
Basic UDI-DI
B-6-133FF
Reference
"REF: USCA00000740, USCA00000743 USCA00000741, USCA00000742 USCA00000744, USCA00000781"
EMDN
W01021306
EMDN description
TROPONIN I/T
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-130F9

Apolipoprotein E (Apo E)Test Kit (Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-130F9
Basic UDI-DI
B-6-130F9
Reference
"REF: USCA00000774, USCA00000778 USCA00000775 USCA00000737 USCA00000776 USCA00000738 USCA00000777 USCA00000739"
EMDN
W0102010499
EMDN description
LIPOPROTEINS - OTHER
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-129Z

Special protein complex quality control products

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-129Z
Basic UDI-DI
B-6-129Z
Reference
"REF: USCA00000624, USCA00000631, USCA00000632, USCA00000633 "
EMDN
W0102152003
EMDN description
SPECIFIC PROTEIN CONTROLS
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-129FQ

Nonesterified Fatty Acid (NEFA) Assay Kit (ACS-ACOD Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-129FQ
Basic UDI-DI
B-6-129FQ
Reference
"REF: USCA00000732, USCA00000735 USCA00000733 USCA00000734, USCA00000736"
EMDN
W01010222
EMDN description
NON ESTERIFIED FATTY ACIDS
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-128FN

Small Dense Low Density Lipoprotein-Cholesterol (sdLDL-C) Assay Kit (Peroxidase Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-128FN
Basic UDI-DI
B-6-128FN
Reference
"REF: USCA00000730 USCA00000728,USCA00000729 USCA00000731,USCA00000772 USCA00000773"
EMDN
W01010221
EMDN description
LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-127FL

Neutrophil gelatinase-associated lipocalin (NGAL)Test Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-127FL
Basic UDI-DI
B-6-127FL
Reference
"REF: USCA00000722, USCA00000725 USCA00000723, USCA00000724 USCA00000726, USCA00000771"
EMDN
W0102010399
EMDN description
TRANSPORT PROTEINS - OTHER
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-126FJ

Cholyglycine(CG)Test Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-126FJ
Basic UDI-DI
B-6-126FJ
Reference
"REF: USCA00000718 USCA00000719, USCA00000768 USCA00000769 USCA00000720, USCA00000767 USCA00000721, USCA00000770"
EMDN
W0102120199
EMDN description
LIVER FUNCTION - OTHER
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-125FG

Inhibin B Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-125FG
Basic UDI-DI
B-6-125FG
Reference
"REF: USIA00000219M, USIA00000220M"
EMDN
W0102050214
EMDN description
INHIBIN A/B (PRENATAL SCREENING)
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-124FE

Anti-β2-Glycoprotein 1 IgA/G/M Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-124FE
Basic UDI-DI
B-6-124FE
Reference
"REF: USIA00000215M, USIA00000216M"
EMDN
W0102100503
EMDN description
ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-123FC

Anti-β2-Glycoprotein 1 IgG Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-123FC
Basic UDI-DI
B-6-123FC
Reference
"REF: USIA00000211M, USIA00000212M"
EMDN
W0102100503
EMDN description
ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-122FA

Anti-β2-Glycoprotein 1 IgA Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-122FA
Basic UDI-DI
B-6-122FA
Reference
"REF: USIA00000209M, USIA00000210M"
EMDN
W0102100503
EMDN description
ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-121F8

Anti-β2-Glycoprotein 1 IgM Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-121F8
Basic UDI-DI
B-6-121F8
Reference
"REF: USIA00000213M, USIA00000214M"
EMDN
W0102100503
EMDN description
ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-120F6

Anti-Cardiolipin IgA/G/M Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-120F6
Basic UDI-DI
B-6-120F6
Reference
"REF: USIA00000207M, USIA00000208M"
EMDN
W0102100501
EMDN description
ANTI-CARDIOLIPIN ANTIBODIES
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-119X

Monoamine Oxidase (MAO) Test Kit (Continuous Monitoring Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-119X
Basic UDI-DI
B-6-119X
Reference
"REF: U87081030M, U87087050M, U87089050M, U87085020M, U87011020M, U87021050M"
EMDN
W01010199
EMDN description
ENZYMES - OTHER
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-119FM

Anti-Cardiolipin IgG Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-119FM
Basic UDI-DI
B-6-119FM
Reference
"REF: USIA00000203M, USIA00000204M"
EMDN
W0102100501
EMDN description
ANTI-CARDIOLIPIN ANTIBODIES
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details