Drills and Handpieces
- Risk class
- Class IIa
- CND nomenclatures code
- L99
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06009544049180
- Basic UDI
- 6009544038759C
- Version date
- March 06, 2025
- Manufacturer last update
- May 11, 2023
- Active status
- No
- Manufacturer name
- Southern Implants (Pty) Ltd
- Country
- South Africa
- Country type
- NON_EU
- Address
- 1 Albert Road Irene
- colin.s@southernimplants.com
- SRN
- SE-AR-000032508
- Country
- Sweden
- Address
- 30 Holmgatan Falun
- RAQ@southernimplants.com
- Competent authority
- Swedish Medical Products Agency
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Portugal
- Market available
- Austria:None~None, Belgium:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Italy:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
- Human tissues
- No
- Animal tissues
- No
SURGICAL INSTRUMENTS, REUSABLE - OTHER
Access comprehensive regulatory information for Drills and Handpieces 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 06009544049180 and manufactured by Southern Implants (Pty) Ltd in South Africa.
This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Swedish Medical Products 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.