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Organization name
UDI-DI code
Reference / catalog number

CareLine HF-Platform — Class IIa MDR by CareLine Solutions

MD Atlas
CareLine Solutions

Manufacturer information

Organization name: CareLine Solutions
SRN: FR-MF-000018321
Manufacturer status: Active

Certificates

Certificate health across this manufacturer's portfolio.

IT343771Issued
Quality management systemNotified body: 1370Expiry: Jun 29, 2030

Related devices

This device is not currently linked to any other device.

EUDAMED last updated this device on Oct 14, 2025

CareLine HF-Platform

37700273460200LU

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CareLine Solutions
UDI-DI code: 03770027346012
Reference / catalog number: Version 2

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Manufacturer information

Organization name: CareLine Solutions
SRN: FR-MF-000018321
Manufacturer status: Active

Critical warnings

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

CW010
Remote management of heart failure is not intended to ensure continuous monitoring of patients or provide them with emergency care. Patients should be informed and educated accordingly

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jul 30, 2025	Still on market

Device identification

Trade name: CareLine HF-Platform
UDI-DI code: 03770027346012
Basic UDI-DI: 37700273460200LU
Reference / catalog number: Version 2
Issuing entity: GS1

Classification

Risk category: Class IIa
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)

Z12059092VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - 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

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

IT343771Issued
Quality management systemNotified body: 1370Expiry: Jun 29, 2030