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DRILL - EUDAMED Registration 00815131029970

Access comprehensive regulatory information for 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 00815131029970 and manufactured by Blue Sky Bio, LLC in United States.

This page provides complete registration details including trade name (Drill Profile D 4.5mm), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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
00815131029970
No
DRILL
Trade Name: Drill Profile D 4.5mm
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Device Description (EMDN)

SURGICAL DENTAL DEVICES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010399
Trade Name
Drill Profile D 4.5mm
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
00815131029970
Basic UDI
081513102DRILLRUC1X6
Version Date
April 23, 2024
Manufacturer Last Update
October 05, 2021
Active Status
No
Manufacturer
Manufacturer Name
Blue Sky Bio, LLC
Country
United States
Country Type
NON_EU
Address
800 Liberty Drive Libertyville
Email
michele.kupcso@accumedix.com
Authorized Representative
SRN
DE-AR-000006218
Country
Germany
Address
71 Langenhagener StraรŸe Langenhagen
Email
info@mdi-europa.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Austria:None~None, France:None~None, Germany:2013-02-12~None, Greece:None~None, Ireland:None~None, Italy:None~None, Portugal:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No