CONDENSER
- Risk class
- Class I
- CND nomenclatures code
- Q010399
- Trade name
- Bone Condenser 10/11
- Implantable
- No
- Reusable
- Yes
- Measuring function
- No
- Primary DI
- 00810060223079
- Basic UDI
- 081006022CONDENSERRUC14W
- Version date
- April 24, 2024
- Manufacturer last update
- October 05, 2021
- Active status
- No
- Manufacturer name
- Blue Sky Bio, LLC
- Country
- United States
- Country type
- NON_EU
- Address
- 800 Liberty Drive Libertyville
- michele.kupcso@accumedix.com
- Name
- mdi Europa GmbH
- SRN
- DE-AR-000006218
- Country
- Germany
- Address
- 71 Langenhagener Straße Langenhagen
- info@mdi-europa.com
- 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
- Human tissues
- No
- Animal tissues
- No
SURGICAL DENTAL DEVICES - OTHER
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 00810060223079 and manufactured by Blue Sky Bio, LLC in United States.
This page provides complete registration details including trade name (Bone Condenser 10/11), 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.