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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) - EUDAMED Registration 08680941148515

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.

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EUDAMED Official Data
Class IIb
08680941148515
No
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)
Trade Name: Ortimplant
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Device Description (EMDN)

OSTEOSYNTHESIS BLADE-PLATE SYSTEMS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P09120504
Trade Name
Ortimplant
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08680941148515
Basic UDI
B-08680941148515
Version Date
March 22, 2024
Manufacturer Last Update
July 27, 2022
Active Status
No
Manufacturer
Country
Türkiye
Country Type
EU_EXTENDED
Address
Kirazlik Mahallesi Samsun
Email
info@aysam.com.tr
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: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
Device Characteristics
Human Tissues
No
Animal Tissues
No