TransFix and TransFix Sample Storage Tubes

EUDAMED

Class A (EU MDR)

Ref TF-01-50

by Caltag Medsystems Ltd

Identity

Device Name: TransFix and TransFix Sample Storage Tubes EUDAMED
Model / Reference: TF-01-50 EUDAMED

Identifiers

Primary DI / UDI-DI: 45060531710031 EUDAMED
Basic UDI-DI: 506053171TFBSST7P EUDAMED
Direct Marketing DI: 45060531710031 EUDAMED
EMDN Code: W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED

Classification

Device Class: Class A EUDAMED
Market of Registration: Austria EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Category: General specimen collection kit

TransFix and TransFix Sample Storage Tubes by Caltag Medsystems Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	506053171TFBSST7P	Class A	Active

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Manufacturer

Manufacturer: Caltag Medsystems Ltd
EUDAMED SRN: GB-MF-000021669
Authorised Representative: Advena Limited MT-AR-000000234

Sources (1)

EUDAMED d35fdbaa-9ab4-481c-b4eb-cdfb2a0705ec 61 fields · synced Jul 10, 2026