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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

external container 1000 ml — Class I MDR by ASSKEA GmbH

MD Atlas
ASSKEA GmbH

EUDAMED last updated this device on Apr 16, 2026

external container 1000 ml

426058604Bag-OneWayYH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ASSKEA GmbH
UDI-DI code: 04260586041514
Reference / catalog number: 39405

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Manufacturer information

Organization name: ASSKEA GmbH
SRN: DE-MF-000005146
Manufacturer status: Active

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Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market

Device identification

Trade name: external container 1000 ml
UDI-DI code: 04260586041514
Basic UDI-DI: 426058604Bag-OneWayYH
Reference / catalog number: 39405
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A060399FLUID COLLECTION BAGS AND SYSTEMS - 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

Certificates

Certificate health across this manufacturer's portfolio.

111138U2Issued
Quality management systemNotified body: 0494Expiry: Mar 8, 2031