PHOTOTHERAPY EYE MASK LARGE

Trade name

PHOTOTHERAPY EYE MASK LARGE

UDI-DI code

08053847360464

Basic UDI-DI

80538473632SM

Reference / catalog number

13678B73

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Phototherapy Eye Mask provides neonatal eye protection during ultraviolet (UV) phototherapy treatment of jaundice. The Phototherapy Eye Mask conforms with EN 170:2002 Clause 5.2 (Scale Number 2-5) for spectral transmittance as appropriate for the indication for use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Large

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

• V0201PHOTOTHERAPY MASKS

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

• CW009

  EUDAMED did not publish a description for this code.
• CW020

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

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