Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Medibino / Alvibino — Class I MDR by Kluba Medical GmbH

MD Atlas
Kluba Medical GmbH

EUDAMED last updated this device on Feb 3, 2022

Medibino / Alvibino

4260764840001XN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Kluba Medical GmbH
UDI-DI code: 04270000009303
Reference / catalog number: 23021703-R

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Kluba Medical GmbH
SRN: DE-MF-000005421
Manufacturer status: Active

Related devices

8100005134260764840001XNOn the market 8100001364260764840001XNOn the market 23021704-R4260764840001XNOn the market Medibino - the baby head guard sweat grey4260764840001XNOn the market Medibino - the baby head guard white/grey4260764840001XNOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: Medibino / Alvibino
UDI-DI code: 04270000009303
Basic UDI-DI: 4260764840001XN
Reference / catalog number: 23021703-R
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

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.

EMDN nomenclature code(s)

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

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification