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DİNAMİK AKSİYEL DİRSEK FIXATOR (DYNAMIC AXIAL ELBOW FIXATOR) - EUDAMED Registration 08698823317546

Access comprehensive regulatory information for DİNAMİK AKSİYEL DİRSEK FIXATOR (DYNAMIC AXIAL ELBOW FIXATOR) 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 08698823317546 and manufactured by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi in Türkiye.

This page provides complete registration details including trade name (AYSAM), 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
08698823317546
No
DİNAMİK AKSİYEL DİRSEK FIXATOR (DYNAMIC AXIAL ELBOW FIXATOR)
Trade Name: AYSAM
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Device Description (EMDN)

EXTERNAL BONE FIXATION SYSTEMS - OTHER

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P09120499
Trade Name
AYSAM
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08698823317546
Basic UDI
B-08698823317546
Version Date
July 02, 2024
Manufacturer Last Update
November 07, 2023
Active Status
No
Manufacturer
Country
Türkiye
Country Type
EU_EXTENDED
Address
Kirazlik Mh 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:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No