Organization name

Ansell Healthcare Europe NV

SRN

BE-MF-000000691

Manufacturer status

Active

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

• Do not re-use

  Re-use could cause post contamination and post-operative complication

• Consult instructions for use

Primary placement in Belgium; available across 32 countries total.

Trade name

SANDEL Petite Skin Marker

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.

10076490622647

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.

5414566SANSM10YD

Reference / catalog number

1011-NS1

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

500

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• 10076490622647× 500 unitsBase unit
  • 20076490625102× 2 units

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

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

• V9004SKIN MARKING DERMOGRAPHIC PENCILS AND PENS

• Class I medical devices in EUDAMED

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