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607 device results listed.

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06935740739573

Detergent for Electrolyte Analyzer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740739573
Basic UDI-DI: 69357407ICAS000042AW
Reference: /
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740739542

ISE A、ISE B、ISE CAL08

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740739542
Basic UDI-DI: 69357407ICAS000039B9
Reference: /
EMDN: W01010403
EMDN description: MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740735360

UD-2300

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740735360
Basic UDI-DI: 69357407IUD000002XE
Reference: /
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740734004

IA-200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740734004
Basic UDI-DI: 69357407IIA000001NM
Reference: /
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740733717

Multiple compound quality control products for biochemical immunity

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740733717
Basic UDI-DI: 69357407ICAS000036B3
Reference: /
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740733694

Multiple biochemical calibrators

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740733694
Basic UDI-DI: 69357407ICAS000034AX
Reference: /
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740733496

Apolipoprotein B (Apo B) Reagent Kit (Immunoturbidimetric Assay)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740733496
Basic UDI-DI: 69357407ICAS000038B7
Reference: /
EMDN: W0102010403
EMDN description: APOLIPOPROTEIN B
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740733441

Apolipoprotein A1 (Apo A1) Assay Kit (Immunoturbidimetric Assay)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740733441
Basic UDI-DI: 69357407ICAS000037B5
Reference: /
EMDN: W0102010401
EMDN description: APOLIPOPROTEIN A I
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740733359

α1-Microglobulin (α1-MG) testing kit (Latex Immunoturbidimetric Assay)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740733359
Basic UDI-DI: 69357407ICAS000033AV
Reference: /
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740732789

Alpha-fetoprotein （AFP）Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740732789
Basic UDI-DI: 69357407IIAS000016F7
Reference: USIA00000168M
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Maintenance agent for Urine Analyzer

URIT D 22

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740731928
Basic UDI-DI: 69357407IUCS000004QS
Reference: U6040022N
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

BF-730 B5R3V6 Flow Cytometer

BF-730 B5R3V6、BF-730 B5R3V5、BF-730 B4R3V3、BF-730 B5R3、BF-730 B5R2、BF-730 B4R2、BF-730 B5、BF-730 B4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740731577
Basic UDI-DI: 69357407IBF000001M5
Reference: /
EMDN: W0202040103
EMDN description: CYTOFLOWMETERS - HIGH ROUTINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

URIT 5C 12 C-Reactive Protein Test Kit (Latex Immunoturbidimetry)

URIT 5C 12

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740731454
Basic UDI-DI: 69357407IBHS000022E6
Reference: /
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740731140

UDE-50、UDE-51

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740731140
Basic UDI-DI: 69357407IUSS0000082M
Reference: /
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

URIT D48 DI Probe Cleaner

URIT D48

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740731133
Basic UDI-DI: 69357407IBHS000008EC
Reference: /
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

BH-5380CRP 5-Part-Diff Auto Hematology Analyzer

BH-5380CRP、BH-5160CRP、BH-5160CS

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740730464
Basic UDI-DI: 69357407IBH000003NB
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

BH-6180 5-Part-Diff Auto Hematology Analyzer

BH-6180、BH-6580、BH-6680、BH-6600、BH-6500、BH-6100

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740730433
Basic UDI-DI: 69357407IBH000004ND
Reference: /
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

URIT HQ 60 Hematology Control

URIT HQ 60

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740726580
Basic UDI-DI: 69357407IBHS000013E5
Reference: /
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

BH-FP68 Fluorescent dye

BH-FP68

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740726573
Basic UDI-DI: 69357407IBHS000015E9
Reference: /
EMDN: W0103010102
EMDN description: SPECIFIC RETICULOCYTE REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

BH-FD68 Fluorescent dye

BH-FD68

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740726559
Basic UDI-DI: 69357407IBHS000017ED
Reference: /
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details