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cobas 8000 B-Gate KIT

cobas 8000 modular analyzer series

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336160992
Basic UDI-DI: 761333601413A9
Reference: 06372546001
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
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 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

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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

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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

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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

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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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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