Organization name

Oscilla A/S

SRN

DK-MF-000002784

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Caution

  Sound stimuli above 100 dB HL can cause potential hearing loss if the exposure time is more than 1.5 minutes.

Primary placement in Denmark; available across 32 countries total.

Trade name

Oscilla® A50 w. H210A headset

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.

05745000311187

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.

5745000311ATM4TW

Reference / catalog number

1233

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Portable PC-controlled audiometer powered through the USB port

Additional information URL

https://oscilla.dk/images/oscilla/IFU_NEW/Id-0226%20IFU%20Oscilla%20A30,%20A50%20and%20A60%20(EN).pdf

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.

• Z121401AUDIOMETERS

• Class IIa medical devices in EUDAMED

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