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Organization name
UDI-DI code
Reference / catalog number

1021784 — Class I MDR by Hegewald Medizinprodukte…

MD Atlas
Hegewald Medizinprodukte GmbH

EUDAMED last updated this device on Mar 27, 2026

1021784

42510422HMP6100ZU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hegewald Medizinprodukte GmbH
UDI-DI code: 04251042207414
Reference / catalog number: 1021784

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Manufacturer information

Organization name: Hegewald Medizinprodukte GmbH
SRN: DE-MF-000006219
Manufacturer status: Active

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Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW010
Gebrauchsanweisung beachten
CW009
Mehrfache Verwendung hat negative Auswirkungen auf die Funktion des Produktes und kann zur Patientengefährdung führen.
CW001
Mehrfache Sterilisation von gebrauchten Beuteln ist nicht zulässig.
CW007
Die Beutel sind nicht zu verwenden, wenn die Verpackung beschädigt ist, die Schutzkappen an den Anschlüssen fehlen oder andere Auffälligkeiten die Unbrauchbarkeit des Produktes vermuten lassen.
CW032
Nach Ablauf des Haltbarkeitsdatums ist das Produkt zu entsorgen und nicht mehr zu verwenden.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04251042207414
Basic UDI-DI: 42510422HMP6100ZU
Reference / catalog number: 1021784
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: 5
Additional product description: MIB2000.G5E.2SBS MIB EVA Mixing and infusion bag 2000ml, yellow-light-protected, 5-pack, EO-sterile
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 2000 MU03

EMDN nomenclature code(s)

A080102PARENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE

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

Certificates

Certificate health across this manufacturer's portfolio.

2608GB448230509Issued
Quality management systemNotified body: 0482Expiry: Jun 20, 2027