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US-MF-000020729Heartflow Analysis v4.x is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by HeartFlow, Inc.. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 18, 2026
0853341006FFRCTSWPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00853341006701
1 warning recorded — scroll inside the panel to see all entries.
CW999Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Belgium; available across 19 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Jul 8, 2025 | Still on market |
| Austria | Apr 1, 2025 | Still on market |
| Germany | Apr 1, 2025 | Still on market |
| Denmark | Apr 1, 2025 | Still on market |
| Spain | Apr 1, 2025 | Still on market |
| Finland | Apr 1, 2025 | Still on market |
| Ireland | Apr 1, 2025 | Still on market |
| Iceland | Apr 1, 2025 | Still on market |
| Italy | Sep 25, 2025 | Still on market |
| Liechtenstein | Apr 1, 2025 | Still on market |
| Malta | Apr 1, 2025 | Still on market |
| Netherlands | Apr 1, 2025 | Still on market |
| Norway | Apr 1, 2025 | Still on market |
| Poland | Apr 1, 2025 | Still on market |
| Portugal | Apr 1, 2025 | Still on market |
| Romania | Apr 1, 2025 | Still on market |
| Sweden | Apr 1, 2025 | Still on market |
| Türkiye | Dec 29, 2025 | Still on market |
| XI | Apr 1, 2025 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00853341006701Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
0853341006FFRCTSWHeartflow Analysis v4.xUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWAREThis device is not currently linked to any other device.
No certificate specifically references this device's Basic UDI-DI.
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.