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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

Awario Gem — Class I MDR by Heart2Save Oy

MD Atlas
Heart2Save Oy

EUDAMED last updated this device on Dec 2, 2021

Awario Gem

64298105834010UN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Heart2Save Oy
UDI-DI code: 06429810583055
Reference / catalog number: 4010

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Manufacturer information

Organization name: Heart2Save Oy
SRN: FI-MF-000004794
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: Awario Gem
UDI-DI code: 06429810583055
Basic UDI-DI: 64298105834010UN
Reference / catalog number: 4010
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.awario.fi/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

C020501ECG ELECTRODES

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

Awario Analysis ServiceB-06429810583000On the market Awario ApplicationB-06429810583017On the market Awario Care64298105833010UFOn the market Awario Care 264298105833010UFOn 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.