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642 device results listed.

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D-6-113F9

Anti-Zona Pellucida 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-6-113F9
Basic UDI-DI: B-6-113F9
Reference: "REF: USIA00000193M, USIA00000194M"
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-112F7

Anti-Endometrium 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-6-112F7
Basic UDI-DI: B-6-112F7
Reference: "REF: USIA00000189M, USIA00000190M"
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-111F5

Anti-Endometrium 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-6-111F5
Basic UDI-DI: B-6-111F5
Reference: "REF: USIA00000191M, USIA00000192M"
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-110F3

Anti-Ovarian 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-6-110F3
Basic UDI-DI: B-6-110F3
Reference: "REF: USIA00000187M, USIA00000188M"
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-109V

Lactate (LAC) Test Kit (Lactate oxidase method)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-109V
Basic UDI-DI: B-6-109V
Reference: "REF: U89482030M, U89489060M, U89485015M, U89411020M, U89420045M"
EMDN: W01010218
EMDN description: LACTATE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-109FJ

Anti-Ovarian 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-6-109FJ
Basic UDI-DI: B-6-109FJ
Reference: "REF: USIA00000185M, USIA00000186M"
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-107FE

Anti-Spermatozoa 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-6-107FE
Basic UDI-DI: B-6-107FE
Reference: "REF: USIA00000183M, USIA00000184M"
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-108FG

Anti-Spermatozoa 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-6-108FG
Basic UDI-DI: B-6-108FG
Reference: "REF: USIA00000181M, USIA00000182M"
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-106FC

Parathyroid Hormone (PTH) 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-6-106FC
Basic UDI-DI: B-6-106FC
Reference: "REF: USIA00000115M, USIA00000116M"
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-105FA

Human Growth Hormone (hGH) 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-6-105FA
Basic UDI-DI: B-6-105FA
Reference: "REF: USIA00000113M, USIA00000114M"
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-104F8

Insulin (INS) 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-6-104F8
Basic UDI-DI: B-6-104F8
Reference: "REF: USIA00000109M, USIA00000110M"
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-103F6

C-peptide (C-P) 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-6-103F6
Basic UDI-DI: B-6-103F6
Reference: "REF: USIA00000107M, USIA00000108M"
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-102F4

Pregnancy-associated Plasma Protein A (PAPP-A) 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-6-102F4
Basic UDI-DI: B-6-102F4
Reference: "REF: USIA00000105M., USIA00000106M "
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-101F2

free-β-Human Chorionic Gonadotropin (free-β-HCG) 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-6-101F2
Basic UDI-DI: B-6-101F2
Reference: "REF: USIA00000103M, USIA00000104M"
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-100EY

Unconjugated Estriol (uE3) 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-6-100EY
Basic UDI-DI: B-6-100EY
Reference: "REF: USIA00000101M, USIA00000102M"
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-4-76V

URIT-12,PH-01,PH-01A

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-76V
Basic UDI-DI: B-4-76V
Reference: /
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-4-86X

HQ-A,HQ 02,HQ 03

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-86X
Basic UDI-DI: B-4-86X
Reference: /
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-4-66T

H12,PH 01

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-66T
Basic UDI-DI: B-4-66T
Reference: /
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-4-46P

PFS 30

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testingSingle use

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-46P
Basic UDI-DI: B-4-46P
Reference: /
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-4-56R

PFS-30,PFS-30A

IVD self-testing devicesIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-56R
Basic UDI-DI: B-4-56R
Reference: /
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details