Medibino baby head guard - changeable cover Tencel grey

Organization name

Kluba Medical GmbH

SRN

DE-MF-000005421

Manufacturer status

Active

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Trade name

Medibino baby head guard - changeable cover Tencel grey

UDI-DI code

04270000009365

Basic UDI-DI

4260764840001XN

Reference / catalog number

23021704-G

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

Doctors and midwives recommend a supine position for safe baby sleep for good reason. After birth, however, babies’ heads are also particularly soft and therefore prone to head deformations. Month by month, the head becomes more stable and the danger of developing a new head deformation continuously decreases. Unfortunately, after about 6 months, deformations that have already occurred also harden and it can take longer and longer for them to fuse. The Medibino baby head guard offers babies the best possible protection against head deformations from the very beginning. It leads to even pressure relief in the recommended supine position and thus protects the baby’s head so that it retains its natural and round shape. Medibino is a patented medical product and can also be used to relieve existing head deformations.

Additional information URL

https://medibino.de/wp-content/uploads/2022/01/Kluba-Gebrausanweisung_eng_200312.pdf

Clinical sizes

No clinical sizes registered for this device.

• V028099NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER

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