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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

ABENA San Premium — Class I MDR by Abena A/S

MD Atlas
Abena A/S

EUDAMED last updated this device on Dec 16, 2025

ABENA San Premium

57035380AIOBr-00I-05001YK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Abena A/S
UDI-DI code: 05713571000489
Reference / catalog number: 1000021303

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Manufacturer information

Organization name: Abena A/S
SRN: DK-MF-000002482
Manufacturer status: Active

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Denmark; available across 1 country total.

Placed on the market in Denmark; per-country availability dates not published.

Device identification

Trade name: ABENA San Premium
UDI-DI code: 05713571000489
Basic UDI-DI: 57035380AIOBr-00I-05001YK
Reference / catalog number: 1000021303
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: 30
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 2

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

ABENA San Premium57035380AIOBr-00I-05001YKOn the market ABENA San Premium57035380AIOBr-00I-05001YKOn the market ABENA San Premium57035380AIOBr-00I-05001YKOn the market ABENA San Premium57035380AIOBr-00I-05001YKOn the market ABENA San Premium57035380AIOBr-00I-05001YKOn 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.