Manufacturing Facility Approvals - Esterline Interface Technologies

Approvals

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Quality System
ISO 9001
ISO 13485

CE Marking
IVD (98/79/EC) MDD (93/42/EC) EMV (89/336/EC) Low Voltage (73/23/EC) Product Safety (89/392/EC) R&TTE (1999/5/EC)

UL Listing
Device Listing UL 61010-1; UL 60950, UL 60601-1 Follow up Service Procedure (E 189 102) Quarterly Plant Inspections

US FDA
Facility Registration No: 300 3366 417
Device Listing UL 61010-1; UL 60950, UL 60601-1 Follow up Service Procedure (E 189 102) Quarterly Plant Inspections

Japanese Ministry of Health
Japanese Accreditation Certificate of Foreign Medical Device Manufacturer BG 21300216