PHOTOTHERAPY MASKS (Pack of 50)

Organization name

GINEVRI srl

SRN

IT-MF-000034527

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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.

Primary placement in Italy; available across 32 countries total.

Trade name

PHOTOTHERAPY MASKS (Pack of 50)

UDI-DI code

18053847360553

Basic UDI-DI

80538473632SM

Reference / catalog number

1645

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

50

Additional product description

The mask should be used to protect the baby's eyes when the baby is undergoing phototherapy. The masks consist of two sterile eyeballs in medical cotton to be positioned over the newborn's eyes using a blackout Velcro mesh, and a white Velcro matrix for fixing on the newborn's skull in 5 points. One size fit all and adaptability to any type of patient and cranial morphology.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Multi-size

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

• V0201PHOTOTHERAPY MASKS