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Phoenix

BD Phoenix™ PMIC/ID-89

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: 30382904486113
Basic UDI-DI: 038290PTZGVJTLS5
Reference: 448611
EMDN: W0104080110
EMDN description: COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM POSITIVES - AUTOMATED
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 23.09.2026 16:25

Manufacturer products Authorised representative products Authorised representative actors View details

CHROMagar™ StrepB base

IVD Class AIVDR 2017/746On the marketAnimal tissues

Manufacturer: CHROMagar™
Manufacturer SRN: FR-MF-000024723
UDI-DI: 03760344760738
Basic UDI-DI: 376034476SB28B89
Reference: SB282(B)
EMDN: W0104010101
EMDN description: DEHYDRATED CULTURE MEDIA (DCM)
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 16:25

Manufacturer products View details

Phoenix

BD Phoenix™ PMIC-89

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: 30382904484386
Basic UDI-DI: 038290OSMLDAIDEK
Reference: 448438
EMDN: W0104080108
EMDN description: GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 23.09.2026 16:25

Manufacturer products Authorised representative products Authorised representative actors View details

06941967239802

CHECK-BFI

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967239802
Basic UDI-DI: 6973262860013827
Reference: 0404301
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 16:23

Manufacturer products Authorised representative products Authorised representative actors View details

Microbiology Slides

SL75-10

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357032888
Basic UDI-DI: 08453570SL75-10A5
Reference: [SL75-10] Microbiology Slides Pneumocystis carinii Two-Well Control Slide
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 23.09.2026 16:23

Manufacturer products Authorised representative products Authorised representative actors View details

Parasite Suspensions

FP06

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357035117
Basic UDI-DI: 08453570FP06JE
Reference: [FP06] Parasite Suspensions Strongyloides stercoralis
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 23.09.2026 16:23

Manufacturer products Authorised representative products Authorised representative actors View details

Parasite Suspensions

FP05

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357035100
Basic UDI-DI: 08453570FP05JC
Reference: [FP05] Parasite Suspensions Ascaris lumbricoides
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 23.09.2026 16:23

Manufacturer products Authorised representative products Authorised representative actors View details

Parasite Suspensions

FP04

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357035094
Basic UDI-DI: 08453570FP04JA
Reference: [FP04] Parasite Suspensions Taenia species
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 23.09.2026 16:23

Manufacturer products Authorised representative products Authorised representative actors View details

BD TRITEST BD TRUCOUNT

BD Tritest™ CD4/CD8/CD3 with BD Trucount™ Tubes

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903424450
Basic UDI-DI: 038290GYJDCNKNBN
Reference: 342445
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 23.09.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors View details

BD MULTITEST

BD Multitest™ IMK Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Becton, Dickinson and Company, BD Biosciences
Manufacturer SRN: US-MF-000017797
UDI-DI: 00382903405039
Basic UDI-DI: 038290QPFUXCDZKZ
Reference: 340503
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 23.09.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunochromatography Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200185
Basic UDI-DI: 69732628600036ZT
Reference: 02-11-03-0001-00
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 23.09.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunochromatography Analyzer

IVD Class ANot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200208
Basic UDI-DI: 69732628600036ZT
Reference: 02-11-03-0005-00
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 23.09.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors View details

Sperm-Cyto Flow Sperm Analyzer (EVL)

EVL

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Legend-Tec Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047100
UDI-DI: 06977357001971
Basic UDI-DI: 697735700197N4
Reference: LGSF0001
EMDN: W02020499
EMDN description: FLOW CYTOMETRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: GRZAN GROUP SL
Last updated: 23.09.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

HemeScreen®

HemeScreen AML

IVD generalIVDDOn the marketProfessional testingReagentSingle useSterile

Manufacturer: Precipio Inc
Manufacturer SRN: US-MF-000053461
UDI-DI: D-USMF000053461HS1PAMLKK
Basic UDI-DI: B-USMF000053461HS1PAMLKK
Reference: HS-1P-AML
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Easy Medical Device CommV
Last updated: 23.09.2026 15:59

Manufacturer products Authorised representative products Authorised representative actors View details

HemeScreen®

HemeScreen AML

IVD generalIVDDOn the marketProfessional testingReagentSterile

Manufacturer: Precipio Inc
Manufacturer SRN: US-MF-000053461
UDI-DI: D-USMF000053461HSPCAMLT2
Basic UDI-DI: B-USMF000053461HSPCAMLT2
Reference: HS-PC-AML
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Easy Medical Device CommV
Last updated: 23.09.2026 15:59

Manufacturer products Authorised representative products Authorised representative actors View details

HemeScreen®

HemeScreen MPN

IVD generalIVDDOn the marketProfessional testingReagentSingle useSterile

Manufacturer: Precipio Inc
Manufacturer SRN: US-MF-000053461
UDI-DI: D-USMF000053461HS5PMPNP8
Basic UDI-DI: B-USMF000053461HS5PMPNP8
Reference: HS-5P-MPN
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Easy Medical Device CommV
Last updated: 23.09.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

HemeScreen®

HemeScreen MPN

IVD generalIVDDOn the marketProfessional testingReagentSterile

Manufacturer: Precipio Inc
Manufacturer SRN: US-MF-000053461
UDI-DI: D-USMF000053461HSPCMPNVB
Basic UDI-DI: B-USMF000053461HSPCMPNVB
Reference: HS-PC-MPN
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Easy Medical Device CommV
Last updated: 23.09.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

HemeScreen®

HemeScreen CLL

IVD generalIVDDOn the marketProfessional testingReagentSterile

Manufacturer: Precipio Inc
Manufacturer SRN: US-MF-000053461
UDI-DI: D-USMF000053461HSPCCLLT9
Basic UDI-DI: B-USMF000053461HSPCCLLT9
Reference: HS-PC-CLL
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Easy Medical Device CommV
Last updated: 23.09.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

Enkeltstyrkemedie

Culture Media - General agar plates and tubes

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106999622
Basic UDI-DI: 5713106CM_GeneralZL
Reference: 99962
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: Denmark
Authorised representative: -
Last updated: 23.09.2026 15:53

Manufacturer products View details

PD-L1 IHC 22C3 pharmDx

SK006

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsHuman tissuesKitProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700571108239
Basic UDI-DI: 570057R0301P3007C021903N6
Reference: SK00621-2
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Denmark
Safety summary (SSCP/SSP): D67624 · Rev. 5.00
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 23.09.2026 15:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details