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EUDAMED last updated this device on Jul 1, 2026
PP13574PATHMATECOACH46Manoa is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Pathmate Technologies AG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
1313574MANOA5002Manoa 51313574MANOA5002
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES1 warning recorded — scroll inside the panel to see all entries.
The Pathmate Coach is not suitable if one or more of the following conditions exist: - Pregnancy: Do not use the app if you are pregnant or think you might be pregnant. - Sleep restriction in the sleep module: Do not use the reduced sleep time if one of the following contraindications applies: a. Epilepsy b. Bipolar disorder c. Untreated excessive sleepiness (hypersomnolence) The Pathmate Coach is intended as a supportive tool for the self-management of cardiovascular risk factors. It does not replace medical advice, diagnosis or treatment. - Always follow the advice of your doctor or medical staff. - Do not make independent treatment decisions based solely on app recommendations. - Incorrect use of the app (e.g. incorrect data entry, incorrect configuration of reminders) can lead to inappropriate recommendations. Check all entries carefully. The app is intended for adults with an increased risk of cardiovascular disease. Excluded from use are: persons under 18, pregnant persons, people with mental disabilities, and people with insufficient language skills. The app does not monitor vital signs in real time and cannot recognise emergencies or acute medical conditions. In case of health problems or an emergency, contact a healthcare professional or emergency services immediately. The medication reminder is only additional support — do not rely on it solely for taking vital medication. Do not use the app in extreme temperatures. In the event of technical problems (software errors, server failures, loss of internet connection), the app may temporarily not function correctly — always verify important information from other reliable sources.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jul 7, 2026 | Still on market |
CH-MF-0000216851000216664Sterile
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 →Certificate health across this manufacturer's portfolio.
1000216664IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →