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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

23.09.2026 17:11

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Device

3578159

Actor

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Active filter:Manufacturer SRN:CN-MF-000011840

642 device results listed.

Page 7 / 33

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D-6-23A6

β-Hydroxybutyrate (β-Hb）Test Kit (β-Hydroxybutyrate Dehydrogenase Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-23A6
Basic UDI-DI
B-6-23A6
Reference
"REF: U84082040M, U84089060M, U84085020M, U84011020M, U84020060M"
EMDN
W01019099
EMDN description
CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:12
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-22A4

Glycated albumin (GA) 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-6-22A4
Basic UDI-DI
B-6-22A4
Reference
"REF: U84281040M, U84282040M, U84289040M, U84285020M, U84211020M, U84220040M"
EMDN
W01010214
EMDN description
GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:12
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-21A2

Ammonia Zinc compound quality control products

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-21A2
Basic UDI-DI
B-6-21A2
Reference
"REF: USCA00000711, USCA00000712, USCA00000713, USCA00000714"
EMDN
W0101050101
EMDN description
ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:12
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-19AF

Ammonia (AMM) Test kit (Glutamate dehydrogenase Assay)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-19AF
Basic UDI-DI
B-6-19AF
Reference
"REF: U86881030M, U86887050M, U86885020M, U86889050M, U86811020M, U86821050M"
EMDN
W01010301
EMDN description
AMMONIA
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:12
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-209Y

5'- Nucleotidase (5'-NT) quality control products

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-209Y
Basic UDI-DI
B-6-209Y
Reference
"REF: USCA00000705, USCA00000706"
EMDN
W0101050299
EMDN description
SPECIFIC CONTROLS (CC) - OTHER
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:12
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-18AD

Leucine aminopeptidase (LAP) Test Kit (L-Leucine p-nitroanilide hydrochloride substrate Assay)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-18AD
Basic UDI-DI
B-6-18AD
Reference
"REF: U86982030M, U86989060M, U86985015M, U86911020M, U86920060M"
EMDN
W01010122
EMDN description
LEUCINE AMINOPEPTIDASE
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-17AB

Adenosine Deaminase Test Kit (Peroxidase Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-17AB
Basic UDI-DI
B-6-17AB
Reference
"REF: U81382045M, U81389045M, U81385015M, U81320045M"
EMDN
W0102019010
EMDN description
ADENOSINE DEAMINASE
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-16T

Homocysteine（HCY）Reagent Kit (Enzymatic Cycling Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-16T
Basic UDI-DI
B-6-16T
Reference
"REF: U83582015M, U83582030M, U83589045M, U83585015M, U83511020M, U83520030M"
EMDN
W01021307
EMDN description
HOMOCYSTEINE
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-16A9

Cerebrospinal Fluid/Urine Total Protein Reagent Kit (Pyrogallol Red Method)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-16A9
Basic UDI-DI
B-6-16A9
Reference
"REF: U82081045M, U82089060M, U82085020M, U82020060M"
EMDN
W01010230
EMDN description
TOTAL PROTEIN
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-15A7

Total Bilirubin Reagent kit (Dichloroaniline Diazo Salt Method)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-15A7
Basic UDI-DI
B-6-15A7
Reference
"REF: U81482040M, U81489060M, U81485020M, U81411020M, U81420060M"
EMDN
W01010203
EMDN description
BILIRUBIN
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-14A5

Direct Bilirubin Reagent Kit (Dichloroaniline Diazo Salt Method)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-14A5
Basic UDI-DI
B-6-14A5
Reference
"REF: U81582040M, U81589060M, U81585020M, U81511020M, U81520060M"
EMDN
W01010203
EMDN description
BILIRUBIN
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-13A3

Enzyme compound quality control products

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-13A3
Basic UDI-DI
B-6-13A3
Reference
"REF: USCA00000707, USCA00000708, USCA00000709, USCA00000710"
EMDN
W0101050201
EMDN description
ENZYME CONTROLS
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-139FT

Electrolyte Analyzer Supporting Reagent(Ion Selective Electrode Method and Pressure Method)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-139FT
Basic UDI-DI
B-6-139FT
Reference
"REF: U0680910M U0680910N USCE00000079 U0670910D1M U0670910D2M U0670910C1M U0670910C2M"
EMDN
W01010403
EMDN description
MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-138FR

Homocysteine quality control material

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-138FR
Basic UDI-DI
B-6-138FR
Reference
REF: USCA00000764、USCA00000790-USCA00000797
EMDN
W0101050299
EMDN description
SPECIFIC CONTROLS (CC) - OTHER
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-6-137FP

Creatine Kinase MB Isoenzymes (CK-MB) quality control products

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
URIT Medical Electronic Co.,Ltd.
Manufacturer SRN
CN-MF-000011840
UDI-DI
D-6-137FP
Basic UDI-DI
B-6-137FP
Reference
"REF: USCA00000623 USCA00000783 USCA00000784 USCA00000785 USCA00000786 USCA00000787 USCA00000788 USCA00000789"
EMDN
W0101050299
EMDN description
SPECIFIC CONTROLS (CC) - OTHER
First on market country
Spain
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
17.07.2026 03:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
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