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cobas 8000 ISE 900 Module

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: 04015630928347
Basic UDI-DI: 761333601372AL
Reference: 05641497001
EMDN: W0201010108
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

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cobas 8000 c 701 Module

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: 04015630928255
Basic UDI-DI: 761333601371AJ
Reference: 05641489001
EMDN: W0201010108
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

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Reaction Cell c 701 / c 702

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630927289
Basic UDI-DI: 761333601343AD
Reference: 04939719001
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

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cobas c 311 analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630925551
Basic UDI-DI: 761333601323A7
Reference: 04826876001
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

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Reaction Cell c 501 / c 502

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630924110
Basic UDI-DI: 761333601327AF
Reference: 04854241001
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Dry Biochemistry Analyzer

SD1080

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020372
Basic UDI-DI: 6978848020372HJ
Reference: A00814000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

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Auto Dry Biochemistry Analyzer

SD3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020266
Basic UDI-DI: 6978848020266HJ
Reference: A00813000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

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Auto Dry Biochemistry Analyzer

SD1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020044
Basic UDI-DI: 6978848020044GW
Reference: A00812000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

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Auto Chemistry Analyzer

SMT-120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020020
Basic UDI-DI: 6978848020020GG
Reference: A00815000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

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Automatic Biochemical Analyzer

UKCA 2000 / UKCA 3000 / UKCA 6500 / UKCA 8800

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Shenzhen Ukin Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000055688
UDI-DI: 06978669682209
Basic UDI-DI: 697866968UKCA3S
Reference: UKCA 2000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:53

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06978189070050

JIE-100

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

Manufacturer: Yantai JIEZI Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000044146
UDI-DI: 06978189070050
Basic UDI-DI: 697818907JZCHAWG
Reference: JIE-100
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:19

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Dry Fluorescence Immunoassay Analyzer

GKYG-500、GKYG-600、GKYG-800、GKYG-1000、GKYG-2000、GKYG-3000

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

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401003
Basic UDI-DI: 697769840GKPD0166E
Reference: GKPD016
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:54

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Chemistry Analyzer ACCENT-400

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514601707
Basic UDI-DI: 59075146Accent400SS
Reference: B08-A0002
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:41

Manufacturer products View details

TECOM

TC6090L, TC6030L, TC220, TC200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Tecom Science Corporation
Manufacturer SRN: CN-MF-000038772
UDI-DI: 06977149630006
Basic UDI-DI: 697714963TKACATK
Reference: TC6090L
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

PINNACLES KunLun Automatic Chemistry Analyzer

KunLun c2800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Pinnacles (Suzhou) Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000039051
UDI-DI: 06976960820009
Basic UDI-DI: 697696082KL7A
Reference: /
EMDN: W0201010108
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 22:05

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06975838802529

MU500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838802529
Basic UDI-DI: 697583880MS003QU
Reference: HE10015
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemistry Analyzer

MS200

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838800631
Basic UDI-DI: 697583880MS200QY
Reference: HE10007
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

MS100

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838800624
Basic UDI-DI: 697583880MS100QT
Reference: HE10005
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic biochemistry analyzer LOC-200

LOC-200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tianjin LOCMEDT Technologies Co.,Ltd.
Manufacturer SRN: CN-MF-000025773
UDI-DI: 06975641350101
Basic UDI-DI: 697564135ABIOALOC200UC
Reference: 30100005
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

06975569870163

Mini 60、CAS100、S120pro、CAS200、CAS300、CAS400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Sinseng Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000024231
UDI-DI: 06975569870163
Basic UDI-DI: 6975569870528KK
Reference: S120pro
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 19:17

Manufacturer products Authorised representative products Authorised representative actors View details