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EUDAMED registration 04710953425220Yes

Tensiomètre au poignet

AViTA CorporationClass IIaEU EUDAMEDTrade name: Tensiomètre au poignet
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Z1203020501
Trade name
Tensiomètre au poignet
Implantable
No
Reusable
No
Measuring function
Yes
Registration information
Primary DI
04710953425220
Basic UDI
B-04710953425220
Version date
January 17, 2025
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
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
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
France
Market available
France:2021-03-02~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 Tensiomètre au poignet 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 04710953425220 and manufactured by AViTA Corporation in Taiwan.

This page provides complete registration details including trade name (Tensiomètre au poignet), 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.