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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

Minze Diary — Class I MDR by Minze NV

MD Atlas
Minze NV

EUDAMED last updated this device on Oct 1, 2024

Minze Diary

54300006769248

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Minze NV
UDI-DI code: 05430000676069
Reference / catalog number: Minze2

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Manufacturer information

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

Related devices

Minze55430000676954EOn 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: Minze Diary
UDI-DI code: 05430000676069
Basic UDI-DI: 54300006769248
Reference / catalog number: Minze2
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: Minze Diary is a portable, single-patient device to track voided volume trends during bladder diary cycles (from morning void to morning void the next day). It can be used by clinicians to receive more objective information about a patient’s lower urinary tract system.
Additional information URL: https://e-ifu.minzehealth.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12169080VARIOUS INSTRUMENTS FOR UROLOGY - HARDWARE ACCESSORIES

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