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HİBRİT HARİCİ FIXATOR EL BİLEK (HYBRID EXTERNAL FIXATOR WRIST) - EUDAMED Registration 08680941160968

Access comprehensive regulatory information for HİBRİT HARİCİ FIXATOR EL BİLEK (HYBRID EXTERNAL FIXATOR WRIST) 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 08680941160968 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
08680941160968
No
HİBRİT HARİCİ FIXATOR EL BİLEK (HYBRID EXTERNAL FIXATOR WRIST)
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
08680941160968
Basic UDI
B-08680941160968
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