Eu Mdd Eu Md Class 2a On The Market ๐Ÿ‡ฎ๐Ÿ‡น Italy

COMPLETE VITAL SIGNS TELEMETRY SYSTEMS

Empatica S.r.L. ยท ๐Ÿ‡ฎ๐Ÿ‡น Italy
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1

Basic Information

Primary DI
00853858006324
Basic UDI-DI Code
B-00853858006324
Reference
E4
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
Empatica S.r.L.

Additional Description

Wearable electronic device intended to be use for monitoring a set of physiological signals in daily file conditions such as: heart rate, skin conductance, body temperature, and activity information of the subject. The E4, is non intended to diagnose a disease or to be used by a trained medical professional, but will be useful for user that need to track those data in reliable and safe way, as if they are using a medical device, outside typical ambulatory conditions

CND Nomenclature Codes

Code Description
Z12030601 COMPLETE VITAL SIGNS TELEMETRY SYSTEMS

Certificates

Type Number
MDD Annex II (excluding section 4) 1876/MDD

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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