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D-PICOPHORZJ

Picophor

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-PICOPHORZJ
Basic UDI-DI: B-PICOPHORZJ
Reference: PCP
EMDN: W020105010201
EMDN description: SEMI-.AUTOMATED ELECTROPHORESIS SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 09:45

Manufacturer products View details

URA - CLINICAL CHEMISTRY ANALYZER

UR-A

IVD generalIVDDNo longer on the marketInstrument

Manufacturer: Medsource Ozone Biomedicals Private Limited
Manufacturer SRN: IN-MF-000042128
UDI-DI: D-MOBPLUR-AVJ
Basic UDI-DI: B-MOBPLUR-AVJ
Reference: UR-A
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 05:08

Manufacturer products Authorised representative products Authorised representative actors View details

URA PREMIO - CLINICAL CHEMISTRY ANALYZER

EC9005

IVD generalIVDDNo longer on the marketInstrument

Manufacturer: Medsource Ozone Biomedicals Private Limited
Manufacturer SRN: IN-MF-000042128
UDI-DI: D-MOBPLEC9005PD
Basic UDI-DI: B-MOBPLEC9005PD
Reference: EC9005
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 05:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-MINIPHORTS55

Miniphor TS

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-MINIPHORTS55
Basic UDI-DI: B-MINIPHORTS55
Reference: MNFTS
EMDN: W0201050101
EMDN description: AUTOMATED ELECTROPHORESIS SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:07

Manufacturer products View details

D-MINIPHOR08Y5

Miniphor 08

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-MINIPHOR08Y5
Basic UDI-DI: B-MINIPHOR08Y5
Reference: MNF08
EMDN: W0201050101
EMDN description: AUTOMATED ELECTROPHORESIS SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:07

Manufacturer products View details

D-MICROPHORVU

Microphor

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-MICROPHORVU
Basic UDI-DI: B-MICROPHORVU
Reference: MCP
EMDN: W020105010203
EMDN description: DENSITOMETERS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:07

Manufacturer products View details

QuickCheck

MBSQCR100

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: MicroBioSensor Ltd
Manufacturer SRN: GB-MF-000021594
UDI-DI: D-MBSQCR100MS
Basic UDI-DI: B-MBSQCR100MS
Reference: MBSQCR100
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: QNET B.V.
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

QuickCheck Cassette

MBSQCC100

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: MicroBioSensor Ltd
Manufacturer SRN: GB-MF-000021594
UDI-DI: D-MBSQCC100JH
Basic UDI-DI: B-MBSQCC100JH
Reference: MBSQCC100
EMDN: W0201069085
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: QNET B.V.
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

UriDoctor R-50S

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testing

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786Self50WG
Basic UDI-DI: B-KR-MF-000015786Self50WG
Reference: 5690
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-ImmuView_Reader_1SE

ImmuView Reader version 1.0

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: D-ImmuView_Reader_1SE
Basic UDI-DI: B-ImmuView_Reader_1SE
Reference: 18344
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 14.07.2026 02:16

Manufacturer products View details

D-HYDRA09PLUSTD

Hydra 09 Plus

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-HYDRA09PLUSTD
Basic UDI-DI: B-HYDRA09PLUSTD
Reference: NHY09
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 00:59

Manufacturer products View details

On Call GU Dual Blood Glucose and Uric Acid Meter

OGM-201

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-GU114-11DK5
Basic UDI-DI: B-GU114-11DK5
Reference: GU114-11D
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-GP920VC

Rightest GP920

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GP920VC
Basic UDI-DI: B-GP920VC
Reference: GP920
EMDN: W020106019092
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

IDA

IDA Health

IVD generalIVDDOn the marketCompanion diagnosticsNear-patient testingProfessional testing

Manufacturer: iSTOC Oy
Manufacturer SRN: FI-MF-000033355
UDI-DI: D-GMDN440824D
Basic UDI-DI: B-GMDN440824D
Reference: 012016
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 14.07.2026 00:42

Manufacturer products View details

RIGHTEST Max Plus Blood Glucose Monitoring System

GM772

IVD Annex II List BIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM772UY
Basic UDI-DI: B-GM772UY
Reference: 772G01
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

On Call Sure Sync Blood Glucose Meter

OGM-212

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-G115-13WKA
Basic UDI-DI: B-G115-13WKA
Reference: G115-13W
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

On Call Sure Blood Glucose Meter

OGM-211

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-G115-13UK6
Basic UDI-DI: B-G115-13UK6
Reference: G115-13U
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

On Call Extra Blood Glucose Meter

OGM-191

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-G115-13HJC
Basic UDI-DI: B-G115-13HJC
Reference: G115-13H
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

On Call Sure Sync Blood Glucose Meter

OGM-212

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-G115-12WK7
Basic UDI-DI: B-G115-12WK7
Reference: G115-12W
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

On Call Sure Blood Glucose Meter

OGM-211

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-G115-12UK3
Basic UDI-DI: B-G115-12UK3
Reference: G115-12U
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details