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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

010342 — Class I MDR by Helmut Schwarz GmbH

MD Atlas
Helmut Schwarz GmbH

EUDAMED last updated this device on Feb 25, 2026

010342

42511257010311D9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Helmut Schwarz GmbH
UDI-DI code: 04251125704397
Reference / catalog number: 010342

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Manufacturer information

Organization name: Helmut Schwarz GmbH
SRN: DE-MF-000015181
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: 04251125704397
Basic UDI-DI: 42511257010311D9
Reference / catalog number: 010342
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: 10
Additional product description: Der melinip Schnabelbecher ECO Breideckel mit 4 mm Auslass ermöglicht die gezielte Aufnahme von dickflüssigen Speisen und angedickten Getränken. Durch die ergonomische Stellung des Mundstücks wird eine angenehme und kontrollierte Anwendung unterstützt. Eine integrierte Luftöffnung mit 6,5 mm Durchmesser erlaubt bei Bedarf den Einsatz eines Trinkhalms und sorgt für eine kontinuierliche Luftzufuhr. Dadurch wird ein gleichmäßiges Trinken bzw. Essen ohne Absetzen erleichtert. Gefertigt aus hochwertigem, robustem Kunststoff ist der Breideckel langlebig und für den täglichen Einsatz geeignet. Er ist mikrowellengeeignet sowie spülmaschinengeeignet bis 93 °C und unterstützt somit eine hygienische Anwendung im Mehrfacheinsatz.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y150999ASSISTIVE EATING AND DRINKING DEVICES - 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.