Organization name

Agfa NV

SRN

BE-MF-000000571

Manufacturer status

Active

Primary placement in Belgium; available across 32 countries total.

Trade name

CRYSTAL FILM CF-B

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.

05414904161883

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.

5414904273005XE

Reference / catalog number

5YH2C

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

100

Additional product description

—

Additional information URL

https://www.agfa.com/he/global/en/internet/library/?language=English&meta_library_category=Hardcopy

Clinical sizes

• 28 MU10
• 35 MU10

1 packaging level registered — each level carries its own UDI-DI.

• 05414904161883× 1 unitBase unit
  • 05414904226742× 5 units

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

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

• Z130106DRY THERMAL PRINTER X-RAY FILMS

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.