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EUDAMED last updated this device on May 27, 2026
B-00851788001655On-X Prosthetic Heart Valve 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 Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00851788001655ONXANE-21(01)00851788001655
European Medical Device Nomenclature — the EU product classification assigned to this device.
P0703020301BILEAFLET MECHANICAL AORTIC VALVES8 warnings recorded — scroll inside the panel to see all entries.
US-MF-000026354692574OTHER
OTHER
Primary placement in Finland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | Nov 20, 2012 | 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 →B-00851788001396On the marketOn-X Prosthetic Heart ValveB-00851788001426On the marketOn-X Prosthetic Heart ValveB-00851788001297On the marketOn-X Prosthetic Heart ValveB-00851788001440On the marketOn-X Prosthetic Heart Valve Instrument HandleB-00851788001150On the marketOn-X Prosthetic Heart Valve Instrument KitB-00851788001730On the marketNo 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.