Organization name

DGS Diagnostics A/S

SRN

DK-MF-000020570

Manufacturer status

Active

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

• Do not re-use
• Consult instructions for use

Primary placement in Denmark; available across 32 countries total.

Trade name

Sanibel Infant EarCup Hydrogel

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.

05711117221053

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.

5711117_P-0000500_R2

Reference / catalog number

8522011

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

2

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.

• 05711117221053× 2 unitsBase unit
  • 05711117217704× 20 units

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

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

• Z12140385EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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