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59 device results listed.

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UniCel DxI 800 Access Immunoassay System

IVD Class ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817275
Basic UDI-DI: 150995909UniCelDxIG9
Reference: 973100
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 23.09.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 800 Access Immunoassay System w/Spot B

IVD Class ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817633
Basic UDI-DI: 150995909UniCelDxIG9
Reference: A71456
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 600 Access Immunoassay System

IVD Class ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817497
Basic UDI-DI: 150995909UniCelDxIG9
Reference: A30260
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 600 Access Immunoassay System w/Spot B

IVD Class ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817640
Basic UDI-DI: 150995909UniCelDxIG9
Reference: A71460
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

06921893001735

NRM411

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001735
Basic UDI-DI: 69218930057077C
Reference: 12000001100
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 10.08.2026 07:03

Manufacturer products Authorised representative products Authorised representative actors View details

NEXgen

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M521NXGXK
Basic UDI-DI: B-++M521NXGXK
Reference: NXG
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Romania
Authorised representative: -
Last updated: 04.08.2026 23:02

Manufacturer products View details

Atellica IM 1600 Analyzer

IVDR_67_TTN_DUB-C_A_INST_1600 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414650623
Basic UDI-DI: 0405686901509VM
Reference: 11764888
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

06926980316938

Kaeser 6800plus

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980316938
Basic UDI-DI: 69269803YQKaeser6800X3
Reference: CK-KR-CLIA-007
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 31.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

06925912715245

iFlash 9000-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715245
Basic UDI-DI: 692591270180HE
Reference: FG0076
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

06925912710431

iFlash 3000-C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912710431
Basic UDI-DI: 692591270141H4
Reference: C6106
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 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

CM-320i Chemiluminescence Immunoassay Analyzer

CM-320i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520036
Basic UDI-DI: 69257945W0201020103D0KA
Reference: 3013370
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 800 Access Immunoassay System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590265373
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: 973100
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM 1600 Analyzer

IVDR_67_TTN_DUB-C_A_INST_1600 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414002026
Basic UDI-DI: 0405686901509VM
Reference: 11066000
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Pulsar 350

Pulsar 350 - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089444764
Basic UDI-DI: 805360894ES0000859
Reference: ES00008
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:56

Manufacturer products View details

cobas e 801 analytical unit

cobas 8000 modular analyzer series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07813338158458
Basic UDI-DI: 761333601561AR
Reference: 08454345001
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:04

Manufacturer products Authorised representative products Authorised representative actors View details

cobas e 801 MSB/MSBL

cobas 8000 modular analyzer series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336158562
Basic UDI-DI: 761333601562AT
Reference: 08459606 001
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 600 Access Immunoassay System

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590341602
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: A30260
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 800 Access Immunoassay System w/Spot B

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590369194
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: A71456
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 600 Access Immunoassay System w/Spot B

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590369224
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: A71460
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

Shine i3910

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140171191
Basic UDI-DI: 697514017Shinei3910HC
Reference: Shine i3910
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details