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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

4512 — Class IIa MDD by Appsens AS

MD Atlas
Appsens AS

EUDAMED last updated this device on Sep 23, 2022

4512

B-7090052220085TA

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Appsens AS
UDI-DI code: D-7090052220085TA
Reference / catalog number: 4512

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Manufacturer information

Organization name: Appsens AS
SRN: NO-MF-000013438
Manufacturer status: Active

Critical warnings

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

CW010
Instructions given in ECG247 APP and user manuals

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Sep 23, 2022	Dec 31, 2027
Norway	Sep 23, 2022	Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: D-7090052220085TA
Basic UDI-DI: B-7090052220085TA
Reference / catalog number: 4512
Issuing entity: EUDAMED

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: ELECTROCARDIOGRAPHIC LONG-TERM AMBULATORY RECORDER SYSTEM AND BELONGING SOFTWARE
Additional information URL: https://ecg247.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-7090052220085TA

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12050403ECG HOLTER RECORDERS

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

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Related devices

1-1709005222ECG247SENSORZ2On the market 2709005222ECG247ELECTRODG6On the market 1-2709005222ECG247SENSORZ2On the market 3709005222ECG247APP6XOn the market 2-2709005222ECG247ELECTRODG6On 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.