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EUDAMED last updated this device on Dec 20, 2022
859401370Z38NTSensomed® Kälte-Spray is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by AVEFLOR, a.s.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
20188375SZ85000020188375
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES2 warnings recorded — scroll inside the panel to see all entries.
Weder länger, noch aus einer kürzeren Entfernung anwenden, um Frostbeulen zu vermeiden. Auf Gesicht, Hals, empfindliche Körperteile oder offene Wunden nicht anwenden. Bei allergischen Reaktionen auf einen der Inhaltsstoffe des Präparats nicht verwenden. Bei Kindern bis 3 Jahre nicht verwenden. Verwendung bei Schwangeren und stillenden Muttern mit Arzt konsultieren. Bei sensiblen Personen kann allergische Hautreaktion verursachen. Bei starker Rötung der behandelten Stelle, bei Frostbeulen oder Blasen nach übermäßiger Sprayanwendung und bei Zweifeln ärztlichen Rat aufsuchen. Die Augen vor dem Kontakt mit dem Spray schützen. Den Spray nicht einatmen.
Behälter steht unter Druck: Kann bei Erwärmung bersten. Von Hitze, heißen Oberflächen, Funken, offenen Flammen sowie anderen Zündquellenarten fernhalten. Nicht rauchen. Nicht gegen offene Flamme oder andere Zündquelle sprühen. Nicht durchstechen oder verbrennen, auch nicht nach Gebrauch. Vor Sonnenbestrahlung schützen. Nicht Temperaturen von mehr als 50°C aussetzen. Darf nicht in die Hände von Kindern gelangen.
Primary placement in Czechia; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Oct 11, 2021 | Still on market |
| Germany | Jan 14, 2022 | Still on market |
CZ-MF-000003103Sterile
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.
25 0380 QR/NBSupplementedNotified 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.
No certificate specifically references this device's Basic UDI-DI.
859401370Z30NBOn the marketMULTINORM KӒLTE-SPRAY859401370Z38NTOn the marketRYM® Protect859401370Z08NJOn the marketSPRAY PLASTER - SÅRPLAST859401370Z08NJOn the marketTrioderm® CARE Chladicí sprej859401370Z38NTOn the marketTrioderm® CARE Kryosprej na odstranění bradavic859401370Z28NQOn the market