4,5 MM 135° AÇILI BIÇAK PLAK YETİŞKİN 12 DELİK ÇELİK 60 MM BIÇAK (4,5 MM 135° ANGLED BLADE PLATE ADULT 12 HOLES SS 60 MM BLADE)
- Risk class
- Class IIb
- CND nomenclatures code
- P09120504
- Trade name
- Ortimplant
- Implantable
- Yes
- Reusable
- No
- Measuring function
- No
- Primary DI
- 08680941148515
- Basic UDI
- B-08680941148515
- Version date
- March 22, 2024
- Manufacturer last update
- July 27, 2022
- Active status
- No
- Manufacturer name
- Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi
- Country
- Türkiye
- Country type
- EU_EXTENDED
- Address
- Kirazlik Mahallesi Samsun
- info@aysam.com.tr
- 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:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:2020-02-04~None, United Kingdom (Northern Ireland only):None~None
- Human tissues
- No
- Animal tissues
- No
OSTEOSYNTHESIS BLADE-PLATE SYSTEMS
Access comprehensive regulatory information for 4,5 MM 135° AÇILI BIÇAK PLAK YETİŞKİN 12 DELİK ÇELİK 60 MM BIÇAK (4,5 MM 135° ANGLED BLADE PLATE ADULT 12 HOLES SS 60 MM BLADE) in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 08680941148515 and manufactured by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi in Türkiye.
This page provides complete registration details including trade name (Ortimplant), 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.