Urology Fiber Optic I XL Fiber
- Risk class
- Class IIa
- CND nomenclatures code
- Z12011099
- Trade name
- İNVAMED
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- D-868240863030496
- Basic UDI
- B-868240863030496
- Version date
- July 25, 2024
- Manufacturer last update
- February 06, 2022
- Active status
- No
- Manufacturer name
- İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.
- Country
- Türkiye
- Country type
- EU_EXTENDED
- Address
- 2010 ALCI OSB MAHALLESİ 06930 ANKARA
- esraakin@invamed.com
- 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
- Human tissues
- No
- Animal tissues
- No
LASER SURGERY INSTRUMENTS - OTHER
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.