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EUDAMED registration 04710953424711Yes

Infrared Ear/ Forehead Thermometer

AViTA CorporationClass IIaEU EUDAMEDTrade name: Infrared Ear/ Forehead Thermometer
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Z1203020501
Trade name
Infrared Ear/ Forehead Thermometer
Implantable
No
Reusable
No
Measuring function
Yes
Registration information
Primary DI
04710953424711
Basic UDI
471095342TCF04TSXN4
Version date
August 09, 2024
Manufacturer last update
June 02, 2023
Active status
Yes
Manufacturer
Manufacturer name
AViTA Corporation
Country
Taiwan
Country type
NON_EU
Address
9F, No.78, Sec. 1 Kwang-Fu Road New Taipei City
Email
Info@avita.com.tw
Authorized representative
Name
MDSS GmbH
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory information
Competent authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Cyprus
Market available
Bulgaria:2024-01-31~None, Cyprus:2024-01-31~None, Finland:2024-01-31~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES

About this record

Access comprehensive regulatory information for Infrared Ear/ Forehead Thermometer in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 04710953424711 and manufactured by AViTA Corporation in Taiwan.

This page provides complete registration details including trade name (Infrared Ear/ Forehead Thermometer), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.