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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

ScaAI Patch Device — Class IIa MDD by SmartCardia SA

MD Atlas
SmartCardia SA

EUDAMED last updated this device on Sep 19, 2023

ScaAI Patch Device

B-07640375610058

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SmartCardia SA
UDI-DI code: 07640375610058
Reference / catalog number: SC-100-07

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Manufacturer information

Organization name: SmartCardia SA
SRN: CH-MF-000030647
Manufacturer status: Active

Critical warnings

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

CW010
see IFU for use

Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: ScaAI Patch Device
UDI-DI code: 07640375610058
Basic UDI-DI: B-07640375610058
Reference / catalog number: SC-100-07
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The SmartCardia ScaAI Patch Device is used to monitor your heart using the SmartCardia Sensor and Patch. This is worn on the body and monitors and saves your vital signals and sends this data to your doctor using the SmartCardia Phone.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

C900399CARDIOVASCULAR SENSORS - OTHER

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

ScaAI PatchB-07640375610041On 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.