05200

Organization name

TECNIMED s.r.l.

SRN

IT-MF-000007598

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW999

  CONTRAINDICATIONS DO NOT USE: - on patients that have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device; - on patients diagnosed with heart disease or epilepsy; - on pregnant women; - on children under 6 months. WARNINGS DO NOT USE: - on open wounds or rashes, or over infected or pathological or abnormal skin conditions, on bleeding or secreting areas and on mucous membranes; - near flammable liquids or gas or if you have used an insect repellent and/or flammable substances (for example: perfume, deodorant, etc), as this device can ignite flammable substances. - with wet hands or on wet skin.
• CW011

  • Do not use/use with caution: - on or around sensitive areas such as mouth, tongue, eyes, ears, internal part of the wrists or palms, fingertips, etc. - if you are sensitive to electric stimulus; • PERSONAL USE ONLY IS RECOMMENDED: use the device on a single patient. In order to avoid the transmission of infections, do not use on more than one patient. • External use only. • When this device is not used according to these Instructions for use, it can cause sensitivity or irritation at the site of application. Discontinue use if irritation occurs. • It is a medical device. Do not use it as a toy.
• CW135

  Keep it out of reach of children or people with limited sensorimotor skills. Small parts can be ingested or inhaled.
• CW010

  Read instructions carefully before using the device

Primary placement in Italy; available across 5 countries total.

Trade name

not provided

UDI-DI code

08022386018532

Basic UDI-DI

8022386EDP01526063RB

Reference / catalog number

05200

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

afterbite electrostimulator that, through the release of electrical micro-impulses, can relieve local symptoms - itching and inflammation - caused by mosquito bites and, in particular, it is intended to: - reduce the itching and the swelling (inflammation)due to mosquito bites, - reduce the consequences of mosquito bites by stopping the urge to scratch.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER