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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

LABELL Optivie Change Complet… — Class I MDR by Ontex BV

MD Atlas
Ontex BV

EUDAMED last updated this device on May 12, 2025

LABELL Optivie Change Complet taille M jour x20

5414874HeavyIncoG5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ontex BV
UDI-DI code: 03250391189861
Reference / catalog number: 975221902820

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Manufacturer information

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

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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.

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 France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Belgium		Still on market

Device identification

Trade name: LABELL Optivie Change Complet taille M jour x20
UDI-DI code: 03250391189861
Basic UDI-DI: 5414874HeavyIncoG5
Reference / catalog number: 975221902820
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: AIO Straight Chassis N2 MEDIUM x20
Additional information URL: https://www.intermarche.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T04010103INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM

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

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Expiration date
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Software identification