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Organization name
UDI-DI code
Reference / catalog number

VROUWSTERK-2XL — Class I MDR by Jack & Troy BV

MD Atlas
Jack & Troy BV

EUDAMED last updated this device on Aug 6, 2025

VROUWSTERK-2XL

5430003401WMZSXS2W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Jack & Troy BV
UDI-DI code: 05430003401347
Reference / catalog number: VROUWSTERK-2XL

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Manufacturer information

Organization name: Jack & Troy BV
SRN: BE-MF-000048330
Manufacturer status: Active

Related devices

VROUWNORMAAL-S5430003401WMZSXS2WOn the market VROUWNORMAAL-XL5430003401WMZSXS2WOn the market MANZEERSTERK-6XL5430003401WMZSXS2WOn the market VROUWULTRA-5XL5430003401WMZSXS2WOn the market VROUWULTRA-2XL5430003401WMZSXS2WOn 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.

Market distribution

Primary placement in Belgium; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05430003401347
Basic UDI-DI: 5430003401WMZSXS2W
Reference / catalog number: VROUWSTERK-2XL
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: Herbruikbaar incontinentieondergoed voor mannen en vrouwen.
Additional information URL: https://www.wohla.shop/
Clinical sizes: 8 MU163

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

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Software identification