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Atellica HA1C_E High Volume Labels (50)

IVDR_67_TTN_DUB-C_A_KIT_HIGH VOLUME LABEL KIT

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414304311
Basic UDI-DI: 0405686902192VM
Reference: 11597090
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica HA1C_E High Volume Bottles (5)

IVDR_67_TTN_DUB-C_A_KIT_HIGH VOLUME BOTTLE KIT

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414304304
Basic UDI-DI: 0405686902190VH
Reference: 11597087
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

04049095260810

RIDA® Vision

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095260810
Basic UDI-DI: 4049095ZG85920000WU
Reference: ZG8592
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 23.07.2026 08:01

Manufacturer products View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820028
Basic UDI-DI: 69332898CE2001EG
Reference: WP13
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820042
Basic UDI-DI: 69332898CE2001EG
Reference: WP16
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

FC-2000 (WP13, WP16, WP18), FC-2100 (WP14, WP17, WP19)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820059
Basic UDI-DI: 69332898CE2001EG
Reference: WP17
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Romania
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820066
Basic UDI-DI: 69332898CE2001EG
Reference: WP18
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820035
Basic UDI-DI: 69332898CE2001EG
Reference: WP14
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820073
Basic UDI-DI: 69332898CE2001EG
Reference: WP19
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension CHK Flex reagent cartridge

IVDR_67_GLA_DUB-C_A_REAG_CHK

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768033124
Basic UDI-DI: 0405686901028UY
Reference: 10481507
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Sample Probe Cleaner

IVDR_67_GLA_DUB-C_A_REAG_Small Probe Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016356
Basic UDI-DI: 0405686901042US
Reference: 10445209
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Cuvette Wash Solution

IVDR_67_GLA_DUB-C_A_REAG_Cuvette Wash Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016332
Basic UDI-DI: 0405686901030UK
Reference: 10445207
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Sample Transfer Module Aliquot Segment

IVDR_67_GLA_DUB-C_A_INST_Sample Transfer Mod Aliquot Segment

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014048
Basic UDI-DI: 0405686901020UG
Reference: 10445571
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Sample Transfer Module Pipette Tips

IVDR_67_GLA_DUB-C_A_INST_Sample Transfer Module Pipette Tips

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014031
Basic UDI-DI: 0405686901021UJ
Reference: 10445570
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Sample Cups

IVDR_67_GLA_DUB-C_A_INST_Sam Cups

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005893
Basic UDI-DI: 0405686901019UX
Reference: 10445041
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EMPTY Flex Reagent Cartridge

IVDR_67_GLA_DUB-C_A_INST_EMPTY

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005886
Basic UDI-DI: 0405686901012UH
Reference: 10445039
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

DCA Vantage Analyzer (Professional Use)

IVDR_69_TTN_DUB-C_A_NPT_INST_DCA-ACR

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414551371
Basic UDI-DI: 0405686901932W4
Reference: 10282970
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

MI mini 90

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600428
Basic UDI-DI: 695441761110RA2N
Reference: NA
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 22.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

MC-200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600336
Basic UDI-DI: 695441762203C1Z8
Reference: NA
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 22.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600343
Basic UDI-DI: 695441762203C1Z8
Reference: NA
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 22.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details