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Urology Fiber Optic I XL Fiber - EUDAMED Registration D-868240863030496

Access comprehensive regulatory information for Urology Fiber Optic I XL Fiber 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 D-868240863030496 and manufactured by İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş. in Türkiye.

This page provides complete registration details including trade name (İNVAMED), manufacturer information, competent authority (Turkish Medicine and Medical Devices Agency), 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.

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EUDAMED Official Data
Class IIa
D-868240863030496
No
Urology Fiber Optic I XL Fiber
Trade Name: İNVAMED
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Device Description (EMDN)

LASER SURGERY INSTRUMENTS - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12011099
Trade Name
İNVAMED
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-868240863030496
Basic UDI
B-868240863030496
Version Date
July 25, 2024
Manufacturer Last Update
February 06, 2022
Active Status
No
Manufacturer
Country
Türkiye
Country Type
EU_EXTENDED
Address
2010 ALCI OSB MAHALLESİ 06930 ANKARA
Email
esraakin@invamed.com
Regulatory Information
Competent Authority
Turkish Medicine and Medical Devices Agency
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Türkiye
Market Available
Austria:2021-05-21~2028-12-31, Belgium:2021-05-21~2028-12-31, Bulgaria:2021-05-21~2028-12-31, Croatia:2021-05-21~2028-12-31, Cyprus:2021-05-21~2028-12-31, Czechia:2021-05-21~2028-12-31, Denmark:2021-05-21~2028-12-31, Estonia:2021-05-21~2028-12-31, Finland:2021-05-21~2028-12-31, France:2021-05-21~2028-12-31, Germany:2021-05-21~2028-12-31, Greece:2021-05-21~2028-12-31, Hungary:2021-05-21~2028-12-31, Iceland:2021-05-21~2028-12-31, Ireland:2021-05-21~2028-12-31, Italy:2021-05-21~2028-12-31, Latvia:2021-05-21~2028-12-31, Liechtenstein:2021-05-21~2028-12-31, Lithuania:2021-05-21~2028-12-31, Luxembourg:2021-05-21~2028-12-31, Malta:2021-05-21~2028-12-31, Netherlands:2021-05-21~2028-12-31, Norway:2021-05-21~2028-12-31, Poland:2021-05-21~2028-12-31, Portugal:2021-05-21~2028-12-31, Romania:2021-05-21~2028-12-31, Slovakia:2021-05-21~2028-12-31, Slovenia:2021-05-21~2028-12-31, Spain:2021-05-21~2028-12-31, Sweden:2021-05-21~2028-12-31, Türkiye:2021-05-21~2028-12-31, United Kingdom (Northern Ireland only):2021-05-21~2028-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No