TruOx

by BioFynder Limited United Kingdom EUDAMED

Ref TX10002, TX10001, TX10003Model TX100

EMDN W0101060699

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	NumberB-15065023763822 Basic UDI-DI	Date27 Apr 2025Registered	StatusActive
European Union	CE/IVDD	NumberB-15065023763822 Basic UDI-DI	Date27 Apr 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Blood Gas Kit
Blood Gas Analyzer
Blood Gas control
Model / Reference: TX10002, TX100, TX10001, TX10003

Primary DI / UDI-DI: 15065023763822, 15065023763815, 15065023763839
Basic UDI-DI: B-15065023763822, 5065023763TX100VT, B-15065023763839
EMDN Code: W0101060699, W0201040101, W0101060607

Device Class: Class IVD General
Class A
Market of Registration: France
Italy

Manufacturer details

EUDAMED SRN: UK-MF-000047512
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from BioFynder Limited

TruVue

IVD General
TruGlyc

IVD General
TruHemo

IVD General
TruAna

IVD General
TruUri

IVD General
TruVue

IVD General

See all devices from BioFynder Limited →

Properties & raw data

Show properties, registry sources and raw records

Reagent YesEUDAMEDNoEUDAMED
Near-Patient Testing
Professional Testing
Surgical Instrument NoEUDAMEDYesEUDAMED

Other properties (7)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Companion Diagnostics: No
New Device: No

Sources (3)

EUDAMED 85f5f909-1e0b-4bb3-8864-1e52dc51f474 61 fields · synced 22 Oct 2026
EUDAMED 15065023763815|5065023763TX100VT 61 fields · synced 18 May 2026
EUDAMED 15065023763839|B-15065023763839 61 fields · synced 18 May 2026