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Organization name
UDI-DI code
Reference / catalog number

2135609 — Class I MDR by Igefa Handelsgesellschaf…

MD Atlas
Igefa Handelsgesellschaft mbH & Co. KG

EUDAMED last updated this device on Dec 29, 2025

2135609

4024009213560111TW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Igefa Handelsgesellschaft mbH & Co. KG
UDI-DI code: 04024009012006
Reference / catalog number: 2135609

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Manufacturer information

Organization name: Igefa Handelsgesellschaft mbH & Co. KG
SRN: DE-MF-000029971
Manufacturer status: Active

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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.

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: 04024009012006
Basic UDI-DI: 4024009213560111TW
Reference / catalog number: 2135609
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: anatomische Premium Vorlage für schwere Inkontinenz, für die hochwertige, wirtschaftliche Inkontinenzversorgung bei schwerer Inkontinenz und zur Nachtversorgung, dank einzigartiger Fixierstreifen für optimalen Produktsitz auch zum Toilettentraining geeignet, Optimal Lock System: für optimale Saugkraft und zuverlässigen Auslaufschutz dank 3lagigem Saugkörper und integrierten, abstehenden Auslaufsperren, Optimal Dry System: für ein trockenes Hautgefühl dank Verteilerauflage, die Flüssigkeit schnell ins Innere des Saugkerns leitet, Optimal Odourstop System: für schnelle Geruchsbindung dank des speziellen Superabsorbers der Gerüche schnell und zuverlässig einschließt, Optimal Soft-Air System: für angenehmes Tragegefühl dank weicher, atmungsaktiver, textilähnlicher Materialien, mit Optimal 2-Check System: für Bestimmung des optimalen Wechselzeitpunkts dank doppeltem Nässeindikator, mit Optimal Fit System: für optimalen Produktsitz dank einzigartiger Fixierstreifen die sicheren Halt in Fixierhosen gewährleisten, Breite 36 cm, Farbe lila, Länge 74 cm, Saugleistung (ISO) 2300 ml, 1 Beutel à 28 Stk, (Krt à 4 Btl).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T04010102SHAPED INCONTINENCE NAPPIES

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

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