Regulatory

International Regulatory Compliance

Sentinelle developed and maintains a Quality System that adheres to the standards and regulations of the U.S., Canada, the European Union, and other countries and organizations of the world. The standards and regulations used in the control of the design, manufacture, packaging, labeling, storage, installation and servicing ensure our finished medical devices are safe and effective.

ISO 13485:2003 Certificate (PDF)

Health Canada Medical Device Licenses

GE (PDF)
Siemens (PDF)
Toshiba (PDF)
Aegis with BRIGHT Software (PDF)
Aegis Navigation (PDF)

FDA Registration(s)

Establishment Registration and Device Listing
510(k) Premarket Notification Summary (GE 1.5T/8Ch)
510(k) Premarket Notification Summary (Aegis Navigation & Pelvic Application) (PDF)
510(k) Premarket Notification Summary (GE 3T/16Ch) (PDF)
Certificate of Registration – Image processing (PDF)
Certificate of Registration – Coil, Magnetic Resonance (PDF)

European Compliance

Europe – CE Marketing Certificates:

MDD 93/42/EEC Certificate (PDF)
MDD Product List (PDF)

Europe – Declarations of Conformity:

Biopsy Grid (PDF)
GE 8 Ch Breast Coil 1.5T (PDF)
Siemens 2/4/8 Ch Breast Coil 1.5T (PDF)
Siemens 2/4/8 Ch Breast Coil 3.0T (PDF)
Toshiba 8 Ch Breast Coil 1.5T (PDF)
Aegis Software + BRIGHT (PDF)

Notified Body Information

Intertek Semko AB
Box 1103
Torshamnsgatan 43
SE-164 22 Kista
intertek-sc.com

Authorized European Representative Information (Regulatory Info Only)

Emergo Europe
Molenstat 15
2513 BH, The Hague
The Netherlands
Phone: +31 (0)70.345.8570
Fax: +31 (0) 70.346.7299
emergogroup.com

ISO 13485:2003 Certified