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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

cobas e 411 analyzer (disk system)

cobas e 411 analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630937103
Basic UDI-DI: 761333601321A3
Reference: 04775201001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

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cobas e 411 analyzer (rack system)

cobas e 411 analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630924721
Basic UDI-DI: 7613336013209Z
Reference: 04775279001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

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Phadia Xplain

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066021126
Basic UDI-DI: 7333066BUDI0033LV
Reference: 81-1013-01
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

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Phadia MIA

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066021102
Basic UDI-DI: 7333066BUDI0130LU
Reference: 81-1009-01
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

Phadia Prime

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066015101
Basic UDI-DI: 7333066BUDI0016LV
Reference: 12-4101-00
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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Phadia 1000

Phadia Instruments

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066001005
Basic UDI-DI: 7333066BUDI0015LT
Reference: 12-3800-01
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

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BIOHIGH-GRADE

HGL-60V

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing High-Grade Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000051358
UDI-DI: 16979511570009
Basic UDI-DI: 697951157HA001FV
Reference: HGL-60V
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 03.07.2026 00:50

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Fully Automated Chemiluminescence Immunoassay Analyzer

SC200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020419
Basic UDI-DI: 6978848020419HK
Reference: A00816000EN0
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: 03.07.2026 00:05

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Microplate ELISA Reader

UKMR 480 / UKMR 960 / UKMR 2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Shenzhen Ukin Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000055688
UDI-DI: 06978669685200
Basic UDI-DI: 697866968UKMR5S
Reference: UKMR 2000
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:53

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Fluorescence Immunochromatographic Analyzer

iTest F100 / iTest F101 / iTest F800 / iTest F2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Shenzhen Ukin Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000055688
UDI-DI: 06978669681004
Basic UDI-DI: 697866968iTestPU
Reference: iTest F100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Microplate Reader

MPR Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780159
Basic UDI-DI: 697850778MPR10VE
Reference: IN0113
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

SMALL DRY FLUORESCENCE IMMUNOASSAY ANALYZER

FIC-H0

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Manufacturer SRN: CN-MF-000027340
UDI-DI: 06978502842074
Basic UDI-DI: 697850284SZYYQ04NK
Reference: FIC-H0
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:36

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06978465230192

Bright i60 Series (including Bright i30, Bright i36, Bright i38, Bright i39,Bright i60, Bright i66, Bright i68, Bright i69 models); Bright i100 Series (includingBright i100, Bright i160, Bright i180, Bright i190 models); etc

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230192
Basic UDI-DI: 697846523FACIAN3
Reference: Bright i60 Series Bright i30
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:33

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06978189070005

JIE-200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Yantai JIEZI Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000044146
UDI-DI: 06978189070005
Basic UDI-DI: 697818907JZMIAY5
Reference: JIE-200
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence lmmunoanalyzer

AI 2600, AI 2610, AI 2620, AI 2660, AI 2680

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: 06978151200096
Basic UDI-DI: 697815120CLIAAI2600Q3
Reference: AI 2600, AI 2610, AI 2620, AI 2660, AI 2680
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic Quantum Dot Fluorescence Immunochromatographic Analyzer

J3-E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chongqing Juce Life Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000053774
UDI-DI: 06977981880263
Basic UDI-DI: 697798188015W
Reference: J3-E
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automated Fecal Immunochemical Test Analyzer

FIT-1000/1200/1600/1800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Cavan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000052933
UDI-DI: 06977568200019
Basic UDI-DI: 697756820FIT-EQSV
Reference: FIT-1000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 22:43

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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

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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