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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

MedibinoNEO Kit (Small) — Class I MDR by Kluba Medical GmbH

MD Atlas
Kluba Medical GmbH

EUDAMED last updated this device on Aug 9, 2024

MedibinoNEO Kit (Small)

4260764840002XQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Kluba Medical GmbH
UDI-DI code: 04260764840991
Reference / catalog number: 51021703-S

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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: MedibinoNEO Kit (Small)
UDI-DI code: 04260764840991
Basic UDI-DI: 4260764840002XQ
Reference / catalog number: 51021703-S
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: For sampling pupose: -One piece MedibinoNEO ring – TG PUR Gel, outer material biocompatible PU film - Size S -5 pieces MedibinoNEO disposable cover cotton knit WITH soft granules - colour coded - Size S
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 200–800 MU24

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.