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254 device results listed.

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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

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

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

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: 06936983107440
Basic UDI-DI: 6970277510002VYT
Reference: ACIR-100
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

06954417600152

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600152
Basic UDI-DI: 695441761106R32K
Reference: NA
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600145

M3 Pro

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600145
Basic UDI-DI: 695441761106R42M
Reference: NA
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600138

NOVEOS X

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600138
Basic UDI-DI: 695441761106R72T
Reference: NA
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

06950191080128

EUROLineCamera

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Euroimmun (Hangzhou) Medical Laboratory Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000029679
UDI-DI: 06950191080128
Basic UDI-DI: 69501910ELC00018U
Reference: CYQ-BL-ELCS-10-0102
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: EUROIMMUN Medizinische Labordiagnostika AG
Last updated: 31.07.2026 20:18

Manufacturer products Authorised representative products Authorised representative actors View details

06950191080043

EUROLineMaster II

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Euroimmun (Hangzhou) Medical Laboratory Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000029679
UDI-DI: 06950191080043
Basic UDI-DI: 69501910ELMII00012X
Reference: CYQ-BL-ELM-20-2050
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: EUROIMMUN Medizinische Labordiagnostika AG
Last updated: 31.07.2026 20:18

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescence Immunoassay Analyzer

Immu F6, Immu F6S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802602737
Basic UDI-DI: 69268026ImmuF60001KS
Reference: Immu F6
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

06925912734864

Tenfly Phoenix-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912734864
Basic UDI-DI: 692591270283HR
Reference: T0247
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

06925912711094

UNION-C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711094
Basic UDI-DI: 692591270144HA
Reference: U6103
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

ImmuView® Reader 2.0

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106000076
Basic UDI-DI: 5713106ImmuView_Read23J8
Reference: 213414
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

BLUESCAN1/ BlueScan Scanner + DR DOT LIC4/ Dr Dot Software

BlueScan/DrDot

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023685013
Basic UDI-DI: 5425023685013VU
Reference: BLUESCAN1 + DR DOT LIC4
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

BlueDiver Instrument

Instrument

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023685006
Basic UDI-DI: 5425023685006VX
Reference: BLUEDIVER1
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

TruVue

TV100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763396
Basic UDI-DI: 5065023763TV100VD
Reference: TV20001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05060599402017
Basic UDI-DI: 5060599401038XK
Reference: RL-CLIA-1A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

AGILITY

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180058
Basic UDI-DI: 506045618AGILITYBB
Reference: 67000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

DSX Automated ELISA System with 4 incubators

DSX

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180010
Basic UDI-DI: 506045618DSXFQ
Reference: 65400
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

DS2 Automated ELISA System with Barcode scanner

DS2

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180003
Basic UDI-DI: 506045618DS2DE
Reference: 62010
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details