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Urine Sediment Analyzer

FUS-360

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520081
Basic UDI-DI: B-06925794520081
Reference: FUS-360
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:36

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis System

MUS-3600

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520005
Basic UDI-DI: B-06925794520005
Reference: MUS-3600
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:36

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Hybrid

FUS-1000

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794515049
Basic UDI-DI: B-06925794515049
Reference: FUS-1000
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Hybrid

FUS-3000Plus

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794515032
Basic UDI-DI: B-06925794515032
Reference: FUS-3000Plus
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:30

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Vaginal Infections Analyzer

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794513083
Basic UDI-DI: B-06925794513083
Reference: GMD-S600
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:29

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Auto-Chemistry Analyzer

CS-1300B

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504753
Basic UDI-DI: B-06925794504753
Reference: CS-1300B
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Hybrid

FUS-2000

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504562
Basic UDI-DI: B-06925794504562
Reference: FUS-2000
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

H-800

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504517
Basic UDI-DI: B-06925794504517
Reference: H-800
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Monitoring Meters

Poctor 800

IVD self-testing devicesIVDDOn the marketInstrumentMicrobial substancesProfessional testingSelf testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600269
Basic UDI-DI: B-06921807600269
Reference: JY06 poctor800
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

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saneo® SV-GD 01 Blood Glucose Meter

EM Tag

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 06424180100918
Basic UDI-DI: B-06424180100918
Reference: SV-GD 01
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

saneo® SV-GD 01 Self-Monitoring Blood Glucose System

EM Tag

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 06424180100628
Basic UDI-DI: B-06424180100628
Reference: SV-GD 01
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

GP Reader NT

IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587740454
Basic UDI-DI: B-06419587740454
Reference: 740450
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

Quick Test Reader

IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587740409
Basic UDI-DI: B-06419587740409
Reference: 740400
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

GastroSoft

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587740195
Basic UDI-DI: B-06419587740195
Reference: 740193
EMDN: W0201020292
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

GP Reader

IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587602332
Basic UDI-DI: B-06419587602332
Reference: 602330
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

4SURE SMART

Blood Glucose Monitoring System

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815559
Basic UDI-DI: B-05420040815559
Reference: GD86
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE Smart Duo

Blood Glucose and 𝝱 Ketone Monitoring System

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815542
Basic UDI-DI: B-05420040815542
Reference: GD87
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

i-ImmunDx™ Analyzer

S03A

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Seinda Biomedical Corporation
Manufacturer SRN: CN-MF-000047055
UDI-DI: 06972976460031
Basic UDI-DI: 697297646S03VG
Reference: S03A-004
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.08.2026 14:08

Manufacturer products Authorised representative products Authorised representative actors View details

Optinuvit Diabetes care Advance Plus Multi-Functional Monitoring System TD-4206

IVD Annex II List BIVDDOn the marketInstrumentNear-patient testingProfessional testingReagentSelf testing

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893239355
Basic UDI-DI: B-04719893239355
Reference: TD-4206
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

FORA COMFORT plus G30a

Blood Glucose Meter

IVD Annex II List BIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893239133
Basic UDI-DI: B-04719893239133
Reference: TD-4241
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details