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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

1 Minute Pour mes Reins — Class I MDD by NEWCARD

MD Atlas
NEWCARD

EUDAMED last updated this device on Feb 24, 2025

1 Minute Pour mes Reins

B-MPR-PS-ALLNT

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: NEWCARD
UDI-DI code: D-MPR-PS-ALLNT
Reference / catalog number: 1 Minute Pour mes Reins

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Manufacturer information

Organization name: NEWCARD
SRN: FR-MF-000029884
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
The patient must be informed that telemonitoring does not constitute emergency care, and that recorded data or alerts are not instantly read and interpreted, but only during the days and hours defined by the telemonitoring operator. In the event of an emergency, the patient must contact an emergency number.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Sep 1, 2019	Still on market

Device identification

Trade name: 1 Minute Pour mes Reins
UDI-DI code: D-MPR-PS-ALLNT
Basic UDI-DI: B-MPR-PS-ALLNT
Reference / catalog number: 1 Minute Pour mes Reins
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Telemonitoring software
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - 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

Related devices

1 Minute Pour mon CœurB-MPC-PS-ALLDWOn 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.