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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

13121041912 — Class I MDR by Ontex BV

MD Atlas
Ontex BV

EUDAMED last updated this device on Sep 18, 2025

13121041912

5414874LightIncoH6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ontex BV
UDI-DI code: 08719587163832
Reference / catalog number: 13121041912

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Manufacturer information

Organization name: Ontex BV
SRN: BE-MF-000003544
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Belgium; available across 2 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
Netherlands		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08719587163832
Basic UDI-DI: 5414874LightIncoH6
Reference / catalog number: 13121041912
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: SHAPED PAD WITH STRIP IBIS N4 (old)
Additional information URL: https://www.ah.nl/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T04010199INCONTINENCE NAPPIES - 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

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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.