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EUDAMED last updated this device on May 26, 2026
B-00851788001532On-X® Ascending Aortic Prosthesis is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by On-X Life Technologies, Inc.. Placed on the EU market in Hungary. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00851788001532ONXAAP-25(01)00851788001532
European Medical Device Nomenclature — the EU product classification assigned to this device.
P07030299MECHANICAL HEART VALVES - OTHER9 warnings recorded — scroll inside the panel to see all entries.
CW010CW267CW009CW001CW007US-MF-000026354693153CW032CW026CW999CW999Primary placement in Hungary; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| HungaryPrimary placement | Apr 8, 2011 | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.B-00851788001747On the marketOn-X® Ascending Aortic ProsthesisB-00851788001549On the marketOn-X® Ascending Aortic ProsthesisB-00851788001518On the marketOn-X® Ascending Aortic ProsthesisB-00851788001501On the marketOn-X® Ascending Aortic ProsthesisB-00851788001525On the market