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Organization name
UDI-DI code
Reference / catalog number

Falck AcuCare — Class IIa MDR by Medixine Oy

MD Atlas
Medixine Oy

EUDAMED last updated this device on Mar 26, 2024

Falck AcuCare

64298300897MXSuiteT8

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Medixine Oy
UDI-DI code: 06429830089728
Reference / catalog number: Falck AcuCare

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Manufacturer information

Organization name: Medixine Oy
SRN: FI-MF-000002552
Manufacturer status: Active

Critical warnings

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

CW018
Consult instructions for use

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Apr 2, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06429830089728
Basic UDI-DI: 64298300897MXSuiteT8
Reference / catalog number: Falck AcuCare
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: Falck Acucare is intended for remote monitoring of basic vital signs at home. It is used to enhance patient’s home care by making it possible to transmit routine vital signs measurements directly to professionals and to provide communication channels that make it easier, safer and more efficient to respond to changes in a patient’s condition.
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

Medixine Suite 1064298300897MXSuiteT8On the market Medixine Suite 1164298300897MXSuiteT8On the market

Certificates

Certificate health across this manufacturer's portfolio.

G10 106226 0001Issued
Quality management systemNotified body: 0123Expiry: Aug 11, 2027