Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

904082680 — Class I MDR by Ontex BV

MD Atlas
Ontex BV

EUDAMED last updated this device on Jul 30, 2024

904082680

5414874LightIncoH6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ontex BV
UDI-DI code: 05604260320967
Reference / catalog number: 904082680

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

150101019285414874LightIncoH6On the market iD Sensitive Form Maxi5414874HeavyIncoG5On the market iD Sensitive Form Maxi Night5414874HeavyIncoG5On the market 127623311105414874HeavyIncoG5On the market NOUVANCE PANTS UNISEX L 12pz5414874HeavyIncoG5On 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.

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 Portugal; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05604260320967
Basic UDI-DI: 5414874LightIncoH6
Reference / catalog number: 904082680
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: Por Si Shaped pad with strips N6
Additional information URL: https://www.ontex.com/
Clinical sizes: No clinical sizes registered for this device.

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