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Organization name
UDI-DI code
Reference / catalog number

Hepalbin®-MaxiCycler5 — Class IIa MDD by Albutec GmbH

MD Atlas
Albutec GmbH

EUDAMED last updated this device on Mar 31, 2025

Hepalbin®-MaxiCycler5

B-04260430940130

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Albutec GmbH
UDI-DI code: 04260430940130
Reference / catalog number: 80005-5

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Manufacturer information

Organization name: Albutec GmbH
SRN: DE-MF-000009769
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

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: Hepalbin®-MaxiCycler5
UDI-DI code: 04260430940130
Basic UDI-DI: B-04260430940130
Reference / catalog number: 80005-5
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

F0199HAEMODIALYSIS FILTERS - OTHER
A0499SOLUTION FILTERS - 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

Related devices

Hepalbin®-MaxiCycler1B-04260430940116On the market Hepalbin®-MaxiCycler2B-04260430940673On the market Hepalbin®-MaxiCycler3B-04260430940123On the market Hepalbin®-MaxiCycler4B-04260430940680On the market Hepalbin®-MaxiCycler6B-04260430940697On the market

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.