Organization name

Phantom Laboratory

SRN

US-MF-000027490

Manufacturer status

Active

D-TSP014KT

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.

Primary placement in Sweden; available across 32 countries total.

Trade name

Tomophan®

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

D-TSP014KT

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-TSP014KT

Reference / catalog number

TSP014

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

EUDAMED

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Tomophan® Phantom, Complete Tomophan™ Phantom includes 28mm image quality test object, 14mm and 28mm tissue spacer, chest wall plate, soft case, and Smári Image Analysis Database Service.

Additional information URL

https://www.phantomlab.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z119080VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.