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EUDAMED last updated this device on Aug 10, 2026
7649996163NOAHP9NOAH Sensor Small is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by OxyPrem AG. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0764999616306602000(01)07649996163066
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z1203020406CEREBRAL OXIMETERS7 warnings recorded — scroll inside the panel to see all entries.
The NOAH Tissue Oximeter System must not be applied on injured or non-intact skin, or on a site of local infection
Do not use the NOAH Tissue Oximeter System, including cables, adjacent to or stacked with other devices or cables. This could result in improper operation. If such use is necessary, the NOAH Tissue Oximeter System and the other device(s) should be observed to verify that both operate normally. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
The information and instructions in the current IFU as well as information and instructions for the products used in combination with the NOAH Tissue Oximeter System must be adhered to. The user must read and understand IFU, including all warning and cautions, prior to use of the NOAH Tissue Oximeter System. IFU must be kept during the lifetime of the product. In case of loss, damage or destruction, contact the manufacturer for replacement.
The OxyShield is a single use component that is provided clean, packaged and ready to use. OxyShield must be disposed of after its use.
Primary placement in Austria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | Aug 30, 2026 | Still on market |
CH-MF-000022643The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Do not use OxyShield after its expiry date
The NOAH Tissue Oximeter System, including its components, must not be used in the MRI environment. Prior to MRI, stop monitoring and ensure that all components are removed from the patient.
Do not use if package is damaged and consult instructions for use
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 →Certificate health across this manufacturer's portfolio.
111154U2IssuedNotified 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 →