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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

Minze5 — Class I MDR by Minze NV

MD Atlas
Minze NV

EUDAMED last updated this device on Oct 2, 2025

Minze5

5430000676954E

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Minze NV
UDI-DI code: 05430000676618
Reference / catalog number: Minze5

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Manufacturer information

Organization name: Minze NV
SRN: BE-MF-000022123
Manufacturer status: Active

Related devices

Minze Diary54300006769248On the market Minze Homecup5430000676944COn the market Minze Hospicup5430000676944COn the market Minze Peehat5430000676944COn the market Minze154300006769146On the market

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: 05430000676618
Basic UDI-DI: 5430000676954E
Reference / catalog number: Minze5
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: https://e-ifu.minzehealth.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12169092VARIOUS INSTRUMENTS FOR UROLOGY - MEDICAL DEVICE SOFTWARE

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

Certificates

Certificate health across this manufacturer's portfolio.

BE23/00000279Amended
Quality management systemNotified body: 1639Expiry: Sep 27, 2028