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Wash Additive

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145056546
Basic UDI-DI: 04033145CC18971FC
Reference: 18971
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Cyprus
Authorised representative: -
Last updated: 30.07.2026 18:26

Manufacturer products View details

CombiWash

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145036418
Basic UDI-DI: 04033145EL18460K5
Reference: 18460
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 30.07.2026 18:26

Manufacturer products View details

Flow Cell Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145018773
Basic UDI-DI: 04033145CC18222DU
Reference: 18222
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Portugal
Authorised representative: -
Last updated: 30.07.2026 18:26

Manufacturer products View details

Atellica POC Solution Display

IVDR_69_TTN_DUB-C_A_NPT_INST_De-Cent. Urine LumIQ Analyzer

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414633428
Basic UDI-DI: 0405686901935WA
Reference: 1.0
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

DCA® Vantage Analyzer (USA)

IVDR_69_TTN_DUB-C_A_NPT_INST_DCA-ACR

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414551364
Basic UDI-DI: 0405686901932W4
Reference: 10282969
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Display IND, UA, NC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414657219
Basic UDI-DI: 0405686901935WA
Reference: 11702311
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Display IDN/MYS UA NC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414657202
Basic UDI-DI: 0405686901935WA
Reference: 11702310
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Display IND, UA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414657103
Basic UDI-DI: 0405686901935WA
Reference: 11702306
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Display IDN/MYS, UA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414657028
Basic UDI-DI: 0405686901935WA
Reference: 11702305
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica LumIQ Module OUS3

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414656427
Basic UDI-DI: 0405686901935WA
Reference: 11702304
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

BG-210 Blood Glucose Monitoring System

BG-201 Blood Glucose Monitoring System

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663922555
Basic UDI-DI: B-06939663922555
Reference: -
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Mission

Expert U500 Urine Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756474816
Basic UDI-DI: 6921756499990026X7
Reference: U213-101-201
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

Mission

Expert U120 Smart Urine Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756474793
Basic UDI-DI: 6921756499990025X5
Reference: U118-101-201
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

FIAflex Fluorescent Immunoassay Analyzer(iFIA-800)

iFIA-800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756471730
Basic UDI-DI: 6921756499990101WU
Reference: F113-10111-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

QUIK-CHECK Ultra Cholesterol Meter

CCM-101

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497637
Basic UDI-DI: 6921756499990069XR
Reference: C111-5037-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Mission Cholesterol Meter

CCM-111

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756475222
Basic UDI-DI: 6921756499990065XH
Reference: C111-2021-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Mission Plus Hb Hemoglobin Meter

Plus Hb

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756471545
Basic UDI-DI: 6921756499990099Y2
Reference: C112-3071-201
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

Mission Hb Hemoglobin Meter

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756471170
Basic UDI-DI: 6921756499990088XV
Reference: C111-3031-201
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

On Call GK Dual Blood Ketone Meter

OGM-161

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756471125
Basic UDI-DI: 6921756499990082XH
Reference: GN115-111-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

On Call GU Dual Blood Glucose & Uric Acid Meter

OGM-201

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470258
Basic UDI-DI: 6921756499990049XK
Reference: GU114-11D-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 29.07.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details