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Phoenix

BD Phoenix™ UNMIC-407

IVD Class BIVDR 2017/746No longer on the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904488797
Basic UDI-DI: 038290XHMNFQKWK3
Reference: 448879
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 23.09.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

Phoenix

BD Phoenix™ UNMIC/ID-407

IVD Class BIVDR 2017/746No longer on the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904487493
Basic UDI-DI: 038290YOVECYMPQA
Reference: 448749
EMDN: W0104080109
EMDN description: COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM NEGATIVES - AUTOMATED
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 23.09.2026 23:07

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D-Dimer (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079761
Basic UDI-DI: 69449040AB74000565X
Reference: 105-046778-00
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.09.2026 23:06

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Objektträger Beschriftungsfeld FLIEDER, Kanten 45° geschliffen

Engelbrecht Objektträger

IVD Class AIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: Engelbrecht Medizin- und Labortechnik GmbH
Manufacturer SRN: DE-MF-000053454
UDI-DI: 04260696182749
Basic UDI-DI: 426069618HUDOBJGX
Reference: 111247A.
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 23:06

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D-Dimer (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079730
Basic UDI-DI: 69449040AB74000565X
Reference: 105-046779-00
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.09.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Calibrators

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079723
Basic UDI-DI: 69449040AB74000565X
Reference: 105-046734-00
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.09.2026 23:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079822
Basic UDI-DI: 69449040AB74000565X
Reference: 105-046738-00
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.09.2026 23:02

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079839
Basic UDI-DI: 69449040AB74000565X
Reference: 105-046735-00
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.09.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079778
Basic UDI-DI: 69449040AB74000565X
Reference: 105-046737-00
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.09.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260054

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260054
Basic UDI-DI: 122000026NATCDIHV
Reference: NATCDI-6MC-IVD
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 23:00

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Objektträger Mattrand 20 mm, Kanten 90° geschliffen

IVD Class AIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: Engelbrecht Medizin- und Labortechnik GmbH
Manufacturer SRN: DE-MF-000053454
UDI-DI: 04260696183029
Basic UDI-DI: 426069618HUDOBJGX
Reference: 111002.
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 22:59

Manufacturer products View details

Objektträger Mattrand 15 mm, Kanten 90° geschliffen

IVD Class AIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: Engelbrecht Medizin- und Labortechnik GmbH
Manufacturer SRN: DE-MF-000053454
UDI-DI: 04260696183043
Basic UDI-DI: 426069618HUDOBJGX
Reference: 111002A.
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 22:58

Manufacturer products View details

Objektträger Mattrand 10 mm, Kanten 90° geschliffen

IVD Class AIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: Engelbrecht Medizin- und Labortechnik GmbH
Manufacturer SRN: DE-MF-000053454
UDI-DI: 04260696183067
Basic UDI-DI: 426069618HUDOBJGX
Reference: 111002B.
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 22:57

Manufacturer products View details

COVID-19/Flu A&B Rapid Antigen Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349148013
Basic UDI-DI: 697334914RJ06MA
Reference: RJ06-1
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 23.09.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Target slide 12

Target slide 12 Target slide holder 12 Target slide 24 Target slide holder 24

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Autobio Labtec Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000012110
UDI-DI: 06973049099257
Basic UDI-DI: 697304909M6005AD
Reference: 31.03.04.0028
EMDN: W02079085
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 23.09.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo S900

AutoLumo S900 AutoLumo S920 AutoLumo S960 AutoLumo S980

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Autobio Labtec Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000012110
UDI-DI: 06973049097369
Basic UDI-DI: 697304909Model017FW
Reference: 07091
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 23.09.2026 22:56

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AutoChem B2000

AutoChem B2000 AutoChem B2200 AutoChem B2600 AutoChem B2800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Autobio Labtec Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000012110
UDI-DI: 06973049096966
Basic UDI-DI: 697304909Model002FH
Reference: 10011
EMDN: W0201010104
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 23.09.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

Colector de Flujo Microcapilar (MFC)

S04A2.2, S04E1.1

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: Seinda Biomedical Corporation
Manufacturer SRN: CN-MF-000047055
UDI-DI: 06972976461175
Basic UDI-DI: 697297646S04VJ
Reference: S04A2.2-020
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: Umedwings Netherlands B.V.
Last updated: 23.09.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06941967243625

Fibrin/fibrinogen Degradation Products (FDP) Reagent Kit (Immunoturbidimetric Method)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243625
Basic UDI-DI: 697326286002812D
Reference: 1300414
EMDN: W0103020502
EMDN description: FIBRINOGEN DEGRADATION PRODUCTS
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06941967243595

D-Dimer Reagent Kit (Immunoturbidimetric Method)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243595
Basic UDI-DI: 697326286002802B
Reference: 1300315
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details