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6,5 MM SPONGIOZ VİDA 32 MM YİVLİ TİTANYUM (6,5 MM CANCELLOUS SCREW 32 MM THREADED TITANIUM) 70 MM - EUDAMED Registration 08680941146351

Access comprehensive regulatory information for 6,5 MM SPONGIOZ VİDA 32 MM YİVLİ TİTANYUM (6,5 MM CANCELLOUS SCREW 32 MM THREADED TITANIUM) 70 MM 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 08680941146351 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
08680941146351
No
6,5 MM SPONGIOZ VİDA 32 MM YİVLİ TİTANYUM (6,5 MM CANCELLOUS SCREW 32 MM THREADED TITANIUM) 70 MM
Trade Name: Ortimplant
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Device Description (EMDN)

INTRAMEDULLARY NAILS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P09120201
Trade Name
Ortimplant
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08680941146351
Basic UDI
B-08680941146351
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