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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

1.0.0 — Class I MDR by heartfish GmbH

MD Atlas
heartfish GmbH

EUDAMED last updated this device on Aug 18, 2022

1.0.0

9120124580001SH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: heartfish GmbH
UDI-DI code: 09120124580019
Reference / catalog number: 1.0.0

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Manufacturer information

Organization name: heartfish GmbH
SRN: AT-MF-000018123
Manufacturer status: Active

Related devices

1.0.09120124580001SHOn the market

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Sep 1, 2022	Dec 31, 2029
Germany	Sep 1, 2022	Dec 31, 2029

Device identification

Trade name: not provided
UDI-DI code: 09120124580019
Basic UDI-DI: 9120124580001SH
Reference / catalog number: 1.0.0
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.heartfish.io/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z129092VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - 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

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.