QUALITY & REGULATIONS
To us quality is meeting our customer’s needs and exceeding their expectations. We believe we are especially apt to that task due to our combination of clinical experience and manufacturing competence. We are very proud of our in-house manufacturing which is based in our production facility in Kongsvinger, Norway.
The in-house factor, and our long experience with product development and clinical use, has proved to be a winning formula for us. We simply believe this gives us an edge in meeting our customers’ requirements for high quality products.
On this page you will find certificates, declarations of conformity, regulatory documents to be supplied with the products, registration information- and device listings and contact information related to adverse events.
ISO & EC CERTIFICATES
ISO 13485 |
EC CERTIFICATE |
EXTENSION LETTER EC CERTIFICATE |
MDD & MDR REGULATORY DOCUMENTS
Click the name of the product family to access the declaration of conformity according to Annex II Excluding section 4 of Council Directive of 93/42/EEC on medical devices, as amended. All class I our products meet the MDR.
MDR Class I |
MDD Class II (Extension) and FDA |
|
Retractors |
MALU |
Impression Trays
|
Mini Lock |
|
Mirrors |
SG Ball hooks |
Bite sticks
|
Rotation wedge
|
|
Brush handle and Mixing stick
|
|
|
Mixing pad |
|
Retainer box
|
Device listing with basic UDI and UDI-DI in EUDAMED is found here
FDA LISTING INFORMATION
Registration Number: 1000439711
FEI Number*: 1000439711
- Please follow the link for more information on establishment Registration.
- Please follow the link for more information on device listing.
MHRA UK REGISTRATION INFORMATION
ADVERSE EVENTS
If you have experienced an adverse event with any of our products please contact us immediately at +47 628 14 898 or sale@sagadental.no