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ANKLE FUSION NAIL Ø 12X160 mm (TI) - EUDAMED Registration D-8699131625835E9

Access comprehensive regulatory information for ANKLE FUSION NAIL Ø 12X160 mm (TI) 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 D-8699131625835E9 and manufactured by Zimed Medikal Sanayi ve Ticaret Limited Şirketi in Turkey.

This page provides complete registration details including trade name (ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ), 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
D-8699131625835E9
No
ANKLE FUSION NAIL Ø 12X160 mm (TI)
Trade Name: ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ
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Device Description (EMDN)

INTRAMEDULLARY NAILS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P09120201
Trade Name
ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-8699131625835E9
Basic UDI
B-8699131625835E9
Version Date
June 08, 2023
Manufacturer Last Update
October 27, 2021
Active Status
No
Manufacturer
Country
Turkey
Country Type
EU_EXTENDED
Address
27580 Aydınlar Mah. 03070 Cad. No:4 ŞEHİTKAMİL 27580 ŞEHİTKAMİL
Email
ubb@zimed.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
Turkey
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, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No