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CONDENSER - EUDAMED Registration 00810060223123

Access comprehensive regulatory information for CONDENSER in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00810060223123 and manufactured by Blue Sky Bio, LLC in United States.

This page provides complete registration details including trade name (Bone Condenser 8/9), 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 I
00810060223123
No
CONDENSER
Trade Name: Bone Condenser 8/9
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Device Description (EMDN)

SURGICAL DENTAL DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010399
Trade Name
Bone Condenser 8/9
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
00810060223123
Basic UDI
081006022CONDENSERRUC14W
Version Date
April 24, 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:2019-11-27~None, Greece:None~None, Ireland:None~None, Italy:None~None, Portugal:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No