TransFix Sample Storage Tubes

EUDAMEDFDA UDI

Class A (EU MDR)

Ref TF-01-2, TF-01-10, TF-01-50

by Caltag Medsystems Ltd

Identity

Trade Name: TransFix Sample Storage Tubes EUDAMED
TransFix FDA UDI
Generic Name: General specimen container IVD, additive/medium FDA UDI
Device Name: TransFix and TransFix Sample Storage Tubes EUDAMED
Model / Reference: TF-01-2, TF-01-10, TF-01-50 EUDAMED
TF-01 FDA UDI

Identifiers

Catalog Number: TF-01-2, TF-01-10, TF-01-50 FDA UDI
Primary DI / UDI-DI: 05060531710033 EUDAMEDFDA UDI
Basic UDI-DI: 506053171TFBSST7P EUDAMED
FDA Product Code: PPM FDA UDI
EMDN Code: W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED
GMDN Term: General specimen container IVD, additive/medium FDA UDI

Classification

Device Class: Class A EUDAMED
Class I FDA UDI
Regulation Number: 864.4010 FDA UDI
Market of Registration: Malta EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: General specimen collection kit

TransFix Sample Storage Tubes by Caltag Medsystems Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	506053171TFBSST7P	Class A	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class A	Pending data

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Manufacturer

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

Sources (3)

EUDAMED 059c3894-6d2c-4497-a6d2-f0de7db560af 61 fields · synced Jun 18, 2026
FDA UDI 2a8be4b1-6718-46dc-b7d9-6444eded3a41 34 fields · synced May 30, 2026
EUDAMED 059c3894-6d2c-4497-a6d2-f0de7db560af-1 61 fields · synced Jun 10, 2026