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Powerbone Bone Cement Bone Drill - EUDAMED Registration 08681781334151

Access comprehensive regulatory information for Powerbone Bone Cement Bone Drill in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 08681781334151 and manufactured by Bonegraft Biomaterials Co. in Turkey.

This page provides complete registration details including trade name (Powerbone), 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 IIa
08681781334151
No
Powerbone Bone Cement Bone Drill
Trade Name: Powerbone
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Device Description (EMDN)

ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
P099002
Trade Name
Powerbone
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08681781334151
Basic UDI
B-08681781334151
Version Date
February 05, 2024
Manufacturer Last Update
November 01, 2021
Active Status
No
Manufacturer
Country
Turkey
Country Type
EU_EXTENDED
Address
7410 Sk. KemalpaลŸa Mh. ฤฐzmir
Email
info@bonegraft.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