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Organization name
UDI-DI code
Reference / catalog number

1021801 — Class I MDR by Hegewald Medizinprodukte…

MD Atlas
Hegewald Medizinprodukte GmbH

EUDAMED last updated this device on Mar 27, 2026

1021801

42510422HMP6100ZU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hegewald Medizinprodukte GmbH
UDI-DI code: 04251042202297
Reference / catalog number: 1021801

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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: 04251042202297
Basic UDI-DI: 42510422HMP6100ZU
Reference / catalog number: 1021801
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: MIB300.ves MIB EVA Mixing and infusion bag 300ml, version single tube, EO-sterile
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 300 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

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.