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Aucheer iMAGIN 1800 Chemiluminescence Immunoassay Analyzer

iMAGIN 1800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038081
UDI-DI: 06974546541256
Basic UDI-DI: 0697454654C1800W8
Reference: C1800
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 16.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Aucheer iRaTe 300 Dry fluorescence immunoassay analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038081
UDI-DI: 06974546541232
Basic UDI-DI: 0697454654L0300YB
Reference: L0300
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 16.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

N Cuvette Segments for BN ProSpec

IVDR_27_MAR EB_A_BN_PS_Cuv

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768012334
Basic UDI-DI: 0405686902111UT
Reference: 10446539
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

N Evaporation Caps for Control Vials (2.5 mL)

IVDR_27_MAR EB_A_N_Eva_Caps

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768012297
Basic UDI-DI: 0405686902112UV
Reference: 10446534
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

N Predilution Wells

IVDR_27_MAR EB_A_N_Predil_Well

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768012174
Basic UDI-DI: 0405686902110UR
Reference: 10446521
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:37

Manufacturer products View details

Dimension Vista LOCI Reaction Vessel

IVDR_67_GLA_DUB-C_A_INST_LOCI Reaction Vessel

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016288
Basic UDI-DI: 0405686901016UR
Reference: 10445212
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Chemistry Wash

IVDR_67_GLA_DUB-C_A_REAG_Chem Wash

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014277
Basic UDI-DI: 0405686901027UW
Reference: 10445052
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Cuvette Cartridge

IVDR_67_GLA_DUB-C_A_INST_Cuvette Cartridge

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014086
Basic UDI-DI: 0405686901011UF
Reference: 10445042
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Reaction Vessels

IVDR_67_GLA_DUB-C_A_INST_Reaction Vessels

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013928
Basic UDI-DI: 0405686901018UV
Reference: 10445044
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Sample Probe Cleaner

IVDR_67_GLA_DUB-C_A_REAG_Sample Probe Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013775
Basic UDI-DI: 0405686901041UQ
Reference: 10445035
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Reagent Probe Cleaner

IVDR_67_GLA_DUB-C_A_REAG_Reagent Probe Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013768
Basic UDI-DI: 0405686901039V5
Reference: 10445036
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Small Sample Container (SSC)

IVDR_67_GLA_DUB-C_A_INST_SSC

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005909
Basic UDI-DI: 0405686901023UN
Reference: 10445040
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE® 2000 Systems Microsampling Tube Caps

IVDR_27_LLB_DUB-C_A_INST_MICROSAMPLING TUBE Caps

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414974064
Basic UDI-DI: 0405686901000UA
Reference: 10385205
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE® 2000 Systems Allergen Tube Caps

IVDR_27_LLB_DUB-C_A_INST_Allergen Tube Caps

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414965734
Basic UDI-DI: 0405686900996WP
Reference: 10282837
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE® 2000 Systems Reaction Tubes

IVDR_27_LLB_DUB-C_A_INST_Reaction Tubes

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414954547
Basic UDI-DI: 0405686901003UG
Reference: 10385206
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE® 2000 XPi Immunoassay System

IVDR_67_LLB_DUB-C_A_INST_XPi

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414945422
Basic UDI-DI: 0405686901006UN
Reference: 10373214
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM 1300 Analyzer

IVDR_67_TTN_DUB-C_A_INST_1300 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414007960
Basic UDI-DI: 0405686901508VK
Reference: 11066001
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 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

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

Atellica NEPH 630 System

IVDR_27_MAR EB_A_INST_ANEPH630

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414006239
Basic UDI-DI: 0405686900854W2
Reference: 11239861
EMDN: W0201020204
EMDN description: NEPHELOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:12

Manufacturer products View details

BN II System

IVDR_27_MAR EB_A_INST_BNII

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414002903
Basic UDI-DI: 0405686900856W6
Reference: 11254820
EMDN: W0201020204
EMDN description: NEPHELOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:12

Manufacturer products View details