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

High waist - black - XL –… — Class I MDR by Entusia BV

MD Atlas
Entusia BV

EUDAMED last updated this device on Feb 12, 2026

High waist - black - XL – normal/combi

5430000433ENTUSIA48

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Entusia BV
UDI-DI code: 05430000433341
Reference / catalog number: 05430000433341

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: Entusia BV
SRN: BE-MF-000007880
Manufacturer status: Active

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: High waist - black - XL – normal/combi
UDI-DI code: 05430000433341
Basic UDI-DI: 5430000433ENTUSIA48
Reference / catalog number: 05430000433341
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)

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

Related devices

Boxer - blue - L - 100ml5430000433ENTUSIA48On the market Boxer - blue - L - normal/combi5430000433ENTUSIA48On the market Boxer - blue - M - 100ml5430000433ENTUSIA48On the market Boxer - blue - M - normal/combi5430000433ENTUSIA48On the market Boxer - blue - S - 100ml5430000433ENTUSIA48On 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.