101115

Organization name

Enzymatica AB

SRN

SE-MF-000002254

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  Do not use {Brand name} if you are hypersensitive/allergic to any of the ingredients. Do not use {Brand name} 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 {Brand name} 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.

Trade name

not provided

UDI-DI code

07340031106009

Basic UDI-DI

73400311CZMSJE

Reference / catalog number

101115

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

ColdZyme is a mouth spray that protects against upper respiratory tract viruses causing common cold and flu-like symptoms. ColdZyme forms a protective moisturizing barrier on the mucous membrane of the oral cavity and throat. The barrier disables viruses and inhibits their ability to spread and multiply.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES