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EUDAMED last updated this device on Aug 15, 2024
73400311CZMSJEColdZyme is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class III. Manufactured by Enzymatica AB. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07340031105040101004(01)07340031105040
European Medical Device Nomenclature — the EU product classification assigned to this device.
V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES1 warning recorded — scroll inside the panel to see all entries.
• Do not use ColdZyme® if you are hypersensitive/allergic to any of the ingredients. • Do not use ColdZyme® after surgical intervention in mouth and/or throat until the wound is healed, without consulting your doctor. • Do not inhale when applying the spray as it may cause irritation of the airways, such as cough and hoarseness. • Keep ColdZyme® out of reach of children, to prevent accidents with small parts. • Consult a doctor if you have a high fever or if your symptoms are more severe than those of a normal common cold, as the symptoms could be due to something else. • To avoid spread of infectious disease, the product should only be used by one person. • For optimal effect, do not eat or drink within 20 minutes after use. • Do not use if pack is damaged or opened.
Primary placement in Sweden; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Oct 1, 2024 | Oct 1, 2027 |
| Iceland | Oct 1, 2024 | Oct 1, 2027 |
SE-MF-000002254EPT 0477.MDR.24/5406EPT 0477.MDR.24/5405The 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.
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.
EPT 0477.MDR.24/5406IssuedEPT 0477.MDR.24/5405IssuedNotified 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 →Notified 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 →