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Drills and Handpieces - EUDAMED Registration 06009544049128

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 06009544049128 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.

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EUDAMED Official Data
Class IIa
06009544049128
No
Drills and Handpieces
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

SURGICAL INSTRUMENTS, REUSABLE - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
L99
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06009544049128
Basic UDI
6009544038759C
Version Date
March 06, 2025
Manufacturer Last Update
May 11, 2023
Active Status
No
Manufacturer
Country
South Africa
Country Type
NON_EU
Address
1 Albert Road Irene
Email
colin.s@southernimplants.com
Authorized Representative
SRN
SE-AR-000032508
Country
Sweden
Address
30 Holmgatan Falun
Email
RAQ@southernimplants.com
Regulatory Information
Competent Authority
Swedish Medical Products Agency
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Portugal
Market Available
Poland:None~None, Portugal:None~None, Romania:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Tรผrkiye:None~None, United Kingdom (Northern Ireland only):None~None, 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
Device Characteristics
Human Tissues
No
Animal Tissues
No