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Dimension Vista Reagent Probe Cleaner

IVDR_67_GLA_DUB-C_A_REAG_Reagent Probe Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016349
Basic UDI-DI: 0405686901039V5
Reference: 10445208
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur XPT Immunoassay System

IVDR_67_TTN_DUB-C_A_INST_ADVIA Centaur XPT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596914
Basic UDI-DI: 0405686902025UZ
Reference: 10711433
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry XPT Probe Wash 0

IVDR_67_TTN_DUB-C_A_REAG_XPT Probe Wash 0

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595504
Basic UDI-DI: 0405686901592W2
Reference: 10718756
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica DL

IVDR_67_TTN_DUB-C_A_INST_DL

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414002347
Basic UDI-DI: 0405686902026V3
Reference: 11068008
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

LaserVision Urine Sediment Analyzer

UD-2300,UD-2310 ,UD-2330

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-7-16Y
Basic UDI-DI: B-7-16Y
Reference: /
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 04:28

Manufacturer products Authorised representative products Authorised representative actors View details

Chemichroma™

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010532
Basic UDI-DI: 880613301053BX
Reference: FPRR058
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Chem 5 v3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156188944
Basic UDI-DI: 8592156CCIN0058SW
Reference: INS00013
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

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XL-1000 with ISE

XL-1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143219
Basic UDI-DI: 8592156CCIN0053SL
Reference: INS00009
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

XL-640 with ISE

XL-640

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143196
Basic UDI-DI: 8592156CCIN0052SJ
Reference: INS00007
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

XL-200 with ISE

XL-200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143189
Basic UDI-DI: 8592156CCIN0051SG
Reference: INS00001
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

XL -180 with ISE

XL -180

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143158
Basic UDI-DI: 8592156CCIN0050SE
Reference: INS00037
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

CHEM-7

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156098977
Basic UDI-DI: 8592156CCIN0056SS
Reference: INS00014
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

SPIN XL

Clinical Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673019235
Basic UDI-DI: 8431673INTF02WM
Reference: 5004100
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:12

Manufacturer products View details

SENTiFIT® 300 Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SENTINEL CH. S.p.A.
Manufacturer SRN: IT-MF-000012556
UDI-DI: 08058056685636
Basic UDI-DI: 805805668CIS30003I1235AJ4
Reference: 550300
EMDN: W0201010299
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:09

Manufacturer products View details

06979845480114

ACA820

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Hunan Runmei Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000017635
UDI-DI: 06979845480114
Basic UDI-DI: 697984548ACA820PC
Reference: RM-R03-013-1.0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973316740325

Speedry Chem

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

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740325
Basic UDI-DI: 697331674DBA00029S
Reference: 68000
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

AILEX

AS-690

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Ailex Technology Group Co., Ltd.
Manufacturer SRN: CN-MF-000018920
UDI-DI: 06970133922996
Basic UDI-DI: 697013392002FE
Reference: LY-MY-SH-03997
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

AILEX

AS-1450

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Ailex Technology Group Co., Ltd.
Manufacturer SRN: CN-MF-000018920
UDI-DI: 06970133922972
Basic UDI-DI: 697013392003FG
Reference: LY-MY-SH-03998
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06971674860006
Basic UDI-DI: 6936895BS00326
Reference: BS003
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer ACCENT-400

ACCENT-400

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514601691
Basic UDI-DI: 59075146Accent400SS
Reference: B08-A0001
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:21

Manufacturer products View details