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IS-MF-000000950Nox RIP Belts Disposable - Medium - 20 sets is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Nox Medical. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Nov 29, 2021
1569431111NOX_RIPBELTS6WPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)15694311110170
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
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 Finland; available across 15 countries total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | Jan 19, 2012 | Still on market |
| Austria | Apr 14, 2012 | Still on market |
| Bulgaria | Oct 31, 2017 | Still on market |
| Cyprus | Feb 19, 2019 | Still on market |
| Germany | Feb 16, 2012 | Still on market |
| Denmark | Feb 22, 2012 | Still on market |
| EL | Jan 26, 2015 | Still on market |
| Spain | Aug 7, 2013 | Still on market |
| France | Jan 26, 2012 | Still on market |
| Italy | Jan 20, 2012 | Still on market |
| Malta | Oct 5, 2015 | Still on market |
| Netherlands | Nov 8, 2012 | Still on market |
| Norway | Feb 14, 2012 | Still on market |
| Sweden | Feb 7, 2012 | Still on market |
| Slovenia | Oct 20, 2021 | 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.
15694311110170Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
1569431111NOX_RIPBELTS6W551030UDI 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.
Z12100585POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES1569431111NOX_RIPBELTS6WOn the marketNox RIP Belts Disposable - Large - 20 sets1569431111NOX_RIPBELTS6WOn the marketNox RIP Belts Disposable - Medium1569431111NOX_RIPBELTS6WOn the marketNox RIP Belts Disposable - Pediatric1569431111NOX_RIPBELTS6WOn the marketNox RIP Belts Disposable - Pediatric - 20 sets1569431111NOX_RIPBELTS6WOn the marketNox RIP Belts Disposable - Small1569431111NOX_RIPBELTS6WOn 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.