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787 device results listed.

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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 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

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

IMMULITE 2000 Systems Diluent Tube Caps

IVDR_27_LLB_DUB-C_A_INST_Diluent Tube Caps

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414972923
Basic UDI-DI: 0405686900998WT
Reference: 10385211
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Allergen Tube Septa

IVDR_27_LLB_DUB-C_A_INST_Allergen Tube Septa

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414965741
Basic UDI-DI: 0405686900997WR
Reference: 10282849
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

MINI VIDAS®

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026351656
Basic UDI-DI: 357302BUDI000293TM
Reference: 410416
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:50

Manufacturer products View details

VIDAS® Quality Control

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026121631
Basic UDI-DI: 357302BUDI000250T3
Reference: 30706
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:50

Manufacturer products View details

DS2 / DSX REAGENT TIPS

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180034
Basic UDI-DI: 506045618DS2DE
Reference: 65920
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

DS2 / DSX SAMPLE TIP

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180041
Basic UDI-DI: 506045618DS2DE
Reference: 65910
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

AGILITY SAMPLE TIPS

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180072
Basic UDI-DI: 506045618AGILITYBB
Reference: 67910
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

AGILITY REAGENT TIPS

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180089
Basic UDI-DI: 506045618AGILITYBB
Reference: 6792-
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

DSX Automated ELISA System with 2 incubators

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180157
Basic UDI-DI: 506045618DSXFQ
Reference: 65200
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details