Organization name

Agfa NV

SRN

BE-MF-000000571

Manufacturer status

Active

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

• P390 – Absorb spillage to prevent material damage.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• P333 – If skin irritation or rash occurs: P310 – Immediately call a POISON CENTER or doctor/physician.
• P308 – IF exposed or concerned: P313 – Get medical advice/attention.
• P305 – IF IN EYES: P310 – Immediately call a POISON CENTER or doctor/physician.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P202 – Do not handle until all safety precautions have been read and understood.
• P201 – Obtain special instructions before use.
• H360 – May damage fertility or the unborn child.
• H318 – Causes serious eye damage.
• H315 – Causes skin irritation.
• H290 – May be corrosive to metals.

Primary placement in Belgium; available across 32 countries total.

Trade name

G334i

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.

05414904006474

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

392UO

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.