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EUDAMED registration 07899330015296No

Optical Zone Marker 5 mm

Mediphacos Industrias Médicas S/AClass IEU EUDAMEDTrade name: Kit for Keraring Implantation
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
L1099
Trade name
Kit for Keraring Implantation
Implantable
No
Reusable
Yes
Measuring function
No
Registration information
Primary DI
07899330015296
Basic UDI
B-07899330015296
Version date
January 10, 2024
Manufacturer last update
November 01, 2021
Active status
No
Manufacturer
Manufacturer name
Mediphacos Industrias Médicas S/A
Country
Brazil
Country type
NON_EU
Address
777 Deputado Cristovam Chiaradia Belo Horizonte
Email
qualidade@mediphacos.com
Authorized representative
Name
Mediphacos Technologies, Unipessoal Lda.
SRN
PT-AR-000037989
Country
Portugal
Address
lote 1 Rua António Champalimaud Lisboa
Email
ricardo.vale@mediphacos.com
Telephone
+351 211 528 398
Regulatory information
Competent authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Portugal
Market available
Austria:None~None, Belgium:None~None, Czechia:None~None, France:None~None, Germany:None~None, Greece:None~None, Italy:None~None, Portugal:None~None, Romania:None~None, Spain:None~None, Turkey:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

MICROSURGERY INSTRUMENTS, REUSABLE - OTHER

About this record

Access comprehensive regulatory information for Optical Zone Marker 5 mm in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 07899330015296 and manufactured by Mediphacos Industrias Médicas S/A in Brazil.

This page provides complete registration details including trade name (Kit for Keraring Implantation), 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.