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

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Organization name
UDI-DI code
Reference / catalog number

810000513 — Class I MDR by Kluba Medical GmbH

MD Atlas
Kluba Medical GmbH

EUDAMED last updated this device on Feb 3, 2022

810000513

4260764840001XN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Kluba Medical GmbH
UDI-DI code: 04010395790499
Reference / catalog number: 810000513

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Manufacturer information

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

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: not provided
UDI-DI code: 04010395790499
Basic UDI-DI: 4260764840001XN
Reference / catalog number: 810000513
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

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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.