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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

09120122921708

MAX 9k

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122921708
Basic UDI-DI: 91201229217K5
Reference: 17-0000-01
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products View details

09120122921609

MAX 45k

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122921609
Basic UDI-DI: 91201229216K3
Reference: 16-0000-01
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products View details

09120122921104

ImageXplorer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122921104
Basic UDI-DI: 91201229211JR
Reference: 11-0000-01
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products View details

HYDROFLEX PLUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tecan Austria GmbH
Manufacturer SRN: AT-MF-000020241
UDI-DI: 09120052071160
Basic UDI-DI: 912005207IVS10080001AP4
Reference: 30190374
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:34

Manufacturer products View details

INFINITE F50 PLUS

Infinite F50 Plus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tecan Austria GmbH
Manufacturer SRN: AT-MF-000020241
UDI-DI: 09120052071146
Basic UDI-DI: 912005207IVS10080000ANZ
Reference: 30183570
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:34

Manufacturer products View details

SW MAGELLAN V7.XSTD

Standard

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Tecan Austria GmbH
Manufacturer SRN: AT-MF-000020241
UDI-DI: 09120052070996
Basic UDI-DI: 912005207IVS10090000APE
Reference: 30183889
EMDN: W0201020292
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:34

Manufacturer products View details

CUBE-S Analyser (700/546)

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

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: 09120044112024
Basic UDI-DI: 912004411CUBE3D
Reference: CA0110
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:33

Manufacturer products View details

08905459006295

SAAEIQ-07

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006295
Basic UDI-DI: 8905459MERILEIAQUANTCJ
Reference: SAAEIQ-07
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

QDx Instacheck™-II

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010204
Basic UDI-DI: 880613301020BG
Reference: FPRR039
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

master diagnóstica

VIT-VS42

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: VITRO, S.A.
Manufacturer SRN: ES-MF-000001498
UDI-DI: 08435804518970
Basic UDI-DI: 8435421200571Y8
Reference: VIT-VS42BC
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:31

Manufacturer products View details

Automatic Specific Protein Analyzer

CP700, CP710, CP720

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778383
Basic UDI-DI: 697806677CP004KR
Reference: /
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Specific Protein Analyzer

CP880, CP870, CP860

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778352
Basic UDI-DI: 697806677CP003KP
Reference: /
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598241783
Basic UDI-DI: 6970277510045Z23
Reference: AFR-602
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983192309
Basic UDI-DI: 6970277510044WZP
Reference: AFR-701
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Lateral Flow (LF) Portable Reader Plus

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983170222
Basic UDI-DI: 6970277510019TZH
Reference: ATR-400
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

16-Channel Fluorescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983136471
Basic UDI-DI: 6970277510015PYV
Reference: AFR-800
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983110389
Basic UDI-DI: 6970277510005QYS
Reference: ACIR-200
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Dry-type Fluorescent Immunoassay Analyzer (Single channel)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983110082
Basic UDI-DI: 6970277510004YZ7
Reference: AFR-600
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983107471
Basic UDI-DI: 6970277510002PYF
Reference: AFR-200S
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details