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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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134 device results listed.

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TruVue

TV600

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763938
Basic UDI-DI: 5065023763TV600013P
Reference: TV60001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 21:40

Manufacturer products Authorised representative products Authorised representative actors View details

TruUri

TU100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763921
Basic UDI-DI: 5065023763TU10001ZG
Reference: TU10001
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 21:40

Manufacturer products Authorised representative products Authorised representative actors View details

TruCell

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763914
Basic UDI-DI: 5065023763TC60001TV
Reference: TC60001
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:36

Manufacturer products Authorised representative products Authorised representative actors View details

TruAna

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763907
Basic UDI-DI: 5065023763TA10001RC
Reference: TA10001
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

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TruHemo

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763891
Basic UDI-DI: 5065023763TH10001U7
Reference: TH10001
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruReno

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763884
Basic UDI-DI: 5065023763TR10001Y9
Reference: TR10001
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruLyta

TL100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763877
Basic UDI-DI: 5065023763TL10001VT
Reference: TL10001
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruCell

Lyse

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763860
Basic UDI-DI: 5065023763LyseAL
Reference: TC10003
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruCell

Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763853
Basic UDI-DI: 5065023763DiluentFN
Reference: TC10002
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruCell

TC100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763846
Basic UDI-DI: 5065023763TC100R8
Reference: TC10001
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruOx

TX100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763815
Basic UDI-DI: 5065023763TX100VT
Reference: TX10001
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruGlyc

TG100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763785
Basic UDI-DI: 5065023763TG100S4
Reference: TG10001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

TV100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763396
Basic UDI-DI: 5065023763TV100VD
Reference: TV20001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruDerma

Dermatophyte PCR Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245349
Basic UDI-DI: B-15065026245349
Reference: TM10002
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Control (FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245332
Basic UDI-DI: B-15065026245332
Reference: TV20046
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Folic Acid Test (FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245325
Basic UDI-DI: B-15065026245325
Reference: TV20045
EMDN: W0102070103
EMDN description: FOLATE
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Vitamin B12 Test (FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245318
Basic UDI-DI: B-15065026245318
Reference: TV20044
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Testo Test (FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245301
Basic UDI-DI: B-15065026245301
Reference: TV20043
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

CEA Test (FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245295
Basic UDI-DI: B-15065026245295
Reference: TV20042
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

E2 Test (FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245288
Basic UDI-DI: B-15065026245288
Reference: TV20041
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details