Inovations to SHARPEN your image
NeoCoil designs each coil to ensure the highest quality of product. NeoCoil is committed to the development of excellence as seen through our engineering and manufacturing.
Regulatory Information
NeoCoil, LLC is a privately held company founded in 2006 to enhance MRI image quality using RF technology.
NeoCoil has established, and continues to maintain, a Quality Management System which is compliant with 21 CFR Part 820 (QSR), ISO standard 13485, CMDR, MDD 93/42, and JPAL MO #169 for the design, development and production of RF coils.
International GMP Certifications
- Canada CMDCAS Certificate (includes ISO 13485:2003 Cert.)
Conformance to Ministerial Ordinance 169
Regulatory Information
Notified Body Information
Project Manager / Product Technical Specialist
BSI Product Services - Healthcare
Kitemark House, Maylands Avenue,
Hemel Hempstead, HP2 4SQ, UK
Tel: +44 (0) 1442 278 597
(from the US dial 011 1442 278 597)
Fax: +44 (0) 1442 278 575
Authorized EU Representative
Ermergo Europe
Molentraat 15
2513 BH. The Hauge
The Netherlands
Tel: (31)(0) 70 345-8570
Fax: (31)(0) 70 347-7299
Website: www.emergogroup.com
Market Authorization Holder
Manager, Quality Assurance Management
GE Yokogawa Medical Systems, Ltd. (GEYMS)
Asahigoka
Hino 191-8503 Japan
Tel: +81-42-585-3366
Fax: +81-42-585-5911