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Active filter:Manufacturer SRN:CN-MF-000011840

607 device results listed.

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D-6-82AN

Gastrin-17 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-6-82AN
Basic UDI-DI: B-6-82AN
Reference: "REF: USIA00000164M, USIA00000165M"
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-81AL

Cancer Antigen 19-9 (CA19-9) 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-6-81AL
Basic UDI-DI: B-6-81AL
Reference: "REF: USIA00000133M, USIA00000134M"
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-80AJ

Pro-gastrin-releasing Peptide (proGRP) 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-6-80AJ
Basic UDI-DI: B-6-80AJ
Reference: "REF: USIA00000145M, USIA00000146M"
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-79AZ

Carcinoembryonic Antigen (CEA) 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-6-79AZ
Basic UDI-DI: B-6-79AZ
Reference: "REF: USIA00000127M, USIA00000128M"
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-78AX

Neuron-specific Enolase (NSE) 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-6-78AX
Basic UDI-DI: B-6-78AX
Reference: "REF: USIA00000143M, USIA00000144M"
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-77AV

Ferritin 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-6-77AV
Basic UDI-DI: B-6-77AV
Reference: "REF: USIA00000117M, USIA00000118M"
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-777

α-Hydroxybutyrate Dehydrogenase Reagent Kit (α-ketobutyric Acid Substrate Method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-777
Basic UDI-DI: B-6-777
Reference: "REF: U84485040M, U84489060M, U84485020M, U84422060M"
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-76AT

Cancer Antigen 72-4 (CA72-4) 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-6-76AT
Basic UDI-DI: B-6-76AT
Reference: "REF: USIA00000135M, USIA00000136M"
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-75AR

Cancer Antigen 50 (CA50) 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-6-75AR
Basic UDI-DI: B-6-75AR
Reference: "REF: USIA00000137M, USIA00000138M"
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-74AP

Cancer Antigen 125 (CA125) 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-6-74AP
Basic UDI-DI: B-6-74AP
Reference: "REF: USIA00000129M, USIA00000130M"
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-73AM

Cancer Antigen 15-3(CA15-3)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-6-73AM
Basic UDI-DI: B-6-73AM
Reference: "REF: USIA00000131M, USIA00000132M"
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-72AK

Squamous Cell Carcinoma Antigen (SCCA) 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-6-72AK
Basic UDI-DI: B-6-72AK
Reference: "REF: USIA00000141M, USIA00000142M"
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-71AH

Pepsinogen Ⅱ (PG Ⅱ) 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-6-71AH
Basic UDI-DI: B-6-71AH
Reference: "REF: USIA00000125M, USIA00000126M"
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-70AF

Human Epididymis Protein 4 (HE4) 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-6-70AF
Basic UDI-DI: B-6-70AF
Reference: "REF: USIA00000151M, USIA00000152M"
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-69AW

Cancer Antigen 242 (CA242) 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-6-69AW
Basic UDI-DI: B-6-69AW
Reference: "REF: USIA00000139M, USIA00000140M"
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-68AU

Cytokeratin 19 Fragment (CYFRA21-1) 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-6-68AU
Basic UDI-DI: B-6-68AU
Reference: "REF: USIA00000149M, USIA00000150M"
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-67AS

Pepsinogen Ⅰ (PG Ⅰ) 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-6-67AS
Basic UDI-DI: B-6-67AS
Reference: "REF: USIA00000123M, USIA00000124M"
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-675

Inorganic Phosphorus Reagent Kit (Phosphomolybdate Method)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-675
Basic UDI-DI: B-6-675
Reference: "REF: U85481045M, U85489060M, U85485020M, U85411075M"
EMDN: W01010307
EMDN description: PHOSPHATE INORGANIC / PHOSPHORUS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-66AQ

β2-Microglobulin (β2-MG) 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-6-66AQ
Basic UDI-DI: B-6-66AQ
Reference: "REF: USIA00000147M, USIA00000148M"
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-65AN

Anti-Mullerian Hormone 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-6-65AN
Basic UDI-DI: B-6-65AN
Reference: "REF: USIA00000221M, USIA00000222M"
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details