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253 device results listed.

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Getein 1150 Immunofluorescence Quantitative Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414795530
Basic UDI-DI: 695441479553KR
Reference: GP1006
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 17:45

Manufacturer products Authorised representative products Authorised representative actors View details

06921893001162

FI-1200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001162
Basic UDI-DI: 692189300020052
Reference: 12000000300
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 11.08.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

06921893025427

NRM-FI-1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893025427
Basic UDI-DI: 69218930001004V
Reference: 12000002900
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 10.08.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

LordsMed CLIA Reader

LM007

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470068
Basic UDI-DI: 890619447LM007FB
Reference: LM007
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Multiplex Immunoassay System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380071
Basic UDI-DI: 697529264007N4
Reference: E203
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Multiplex Immunoassay System

P16s

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380064
Basic UDI-DI: 697529264006N2
Reference: E202
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Multiplex Immunoassay System

P16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380057
Basic UDI-DI: 697529264005MY
Reference: E201
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

lumiflx16s

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380040
Basic UDI-DI: 697529264004MW
Reference: E104
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

lumilite8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380026
Basic UDI-DI: 697529264002MS
Reference: E102
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

lumiflx16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380019
Basic UDI-DI: 697529264001MQ
Reference: E101
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dräger DrugTest 5000 Analyzer

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Dräger Safety AG & Co. KGaA
Manufacturer SRN: DE-MF-000014172
UDI-DI: 04026056064922
Basic UDI-DI: B-04026056064922
Reference: 8319900
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 03:04

Manufacturer products View details

Automated CLEIA system

DNK-MiniCL8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380187
Basic UDI-DI: 697529264012MV
Reference: E105
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

DNK-MiniCL16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380170
Basic UDI-DI: 697529264011MT
Reference: E106
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

lumilite8s

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380033
Basic UDI-DI: 697529264003MU
Reference: E103
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

TV600

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763938
Basic UDI-DI: 5065023763TV600013P
Reference: TV60001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 21:40

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDiver Instrument 2

INSTRUMENT II

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023685044
Basic UDI-DI: 5425023685044W7
Reference: BLUEDIVER2
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: -
Last updated: 04.08.2026 21:39

Manufacturer products View details

skyla

HI-P01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Skyla Corporation Hsinchu Science Park Branch
Manufacturer SRN: TW-MF-000007751
UDI-DI: 04719878650021
Basic UDI-DI: 471987865801-000VN
Reference: 801-000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors 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

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