Eu Mdr Eu Md Class 2b On The Market

TECHNOLAS TENEO 317 Model 2 w/ ANTERION

Acquisition and processing of diagnostic data to treat refractive errors referred to an abnormal refractive condition (myopia (ICD-10: H52.1), hyperopia (ICD-10: H52.0), presbyopia (ICD-10: H52.4), with or without astigmatism ICD-10: H52.2.) of the eye in which images fail to focus upon the retina.

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
04050555106296
Basic UDI-DI Code
4050555B00099K
Reference
70010022TPV
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

System consisting of a Teneo and an ophthalmologic diagnostic device including its accessories package.

Medical Purpose

Acquisition and processing of diagnostic data to treat refractive errors referred to an abnormal refractive condition (myopia (ICD-10: H52.1), hyperopia (ICD-10: H52.0), presbyopia (ICD-10: H52.4), with or without astigmatism ICD-10: H52.2.) of the eye in which images fail to focus upon the retina.

CND Nomenclature Codes

Code Description
Z12011001 EXCIMER SURGICAL LASER

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