Organization name

Agfa NV

SRN

BE-MF-000000571

Manufacturer status

Active

13 warnings recorded — scroll inside the panel to see all entries.

• P391 – Collect spillage.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• P308 – IF exposed or concerned: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
• P308 – IF exposed or concerned: P313 – Get medical advice/attention.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P273 – Avoid release to the environment.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• H410 – Very toxic to aquatic life with long lasting effects.
• H351 – Suspected of causing cancer.
• H341 – Suspected of causing genetic defects.
• H335 – May cause respiratory irritation.
• H319 – Causes serious eye irritation.
• H317 – May cause an allergic skin reaction.

Primary placement in Belgium; available across 32 countries total.

Trade name

G153

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.

05414904016848

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.

5414904272985ZC

Reference / catalog number

HT536

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.

GS1

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

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Z11079085VARIOUS X-RAY FILM IMAGING SUPPORT INSTRUMENTS - CONSUMABLES

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.