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EUDAMED last updated this device on Nov 24, 2025
5410765PixieN2OGKSYYLEND FREEZE EXCEL is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Oystershell NV. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0541076500842807011678(01)05410765008428
European Medical Device Nomenclature — the EU product classification assigned to this device.
M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES14 warnings recorded — scroll inside the panel to see all entries.
OTHER
"Instructions for use: Read information insert (inside box) carefully for all instructions and additional precautions and contra-indications before using NITROFREEZE. READ ALL INSTRUCTIONS CAREFULLY BEFORE USING NITROFREEZE. "
Primary placement in Finland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | — | Still on market |
BE-MF-000011797The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Precautions
Do not use the product after the expiry date as stated on the package.
Keep out of the sight and reach of children. Contains small parts.
Nitrous oxide is a non-toxic, non-flammable gas, but it will support combustion in case of fire. Keep away from heat/sparks/open flames/hot surfaces. Do not smoke or use near a naked flame.
Pressurized container. May burst if heated. Do not pierce or burn even after use - the pen is under high pressure and cannot be opened.
Do not inhale nitrous oxide. Breathing the contents is hazardous. Only use in well-ventilated places. Breathing the contents is hazardous – symptoms can include feeling dizzy or confusion and headache.
Only use in well-ventilated places.
symptoms can include feeling dizzy or confusion and headache.
"Do not use NITROFREEZE if you are pregnant or breastfeeding*. *There is no clinical data on the use of NITROFREEZE by pregnant or breastfeeding women"
If product gets into the eyes, flush with water for 15 minutes and seek medical help immediately.
If product gets into the eyes, flush with water for 15 minutes and seek medical help immediately.
Do not reuse the applicator tip.
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 →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.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.
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