Oscilla ® A50 DD65 headset

Organization name

Oscilla A/S

SRN

DK-MF-000002784

Manufacturer status

Active

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

• CW011

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

Primary placement in Denmark; available across 32 countries total.

Trade name

Oscilla ® A50 DD65 headset

UDI-DI code

05745000311170

Basic UDI-DI

5745000311ATM4TW

Reference / catalog number

1232

Issuing entity

GS1

Risk category

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