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Since its inception in 2001, Otter Medical has made remarkable
progress towards becoming a leading medical device innovator
and manufacturer. Some of the major milestones we have achieved
include :
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September, 2001
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Company was established in China with support
from the Jiangsu Bureau of Foreign Trade and Economic
Cooperation as the "Supported and Encouraged Foreign
Venture Development of People's Republic of China".
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August, 2002
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The Otter Auto-destruct Safety Syringe received
China's Medical Instrument Registration Certificate
for Single-Use Safety Syringe (With Needle) issued by
State Bureau of Food and Drug Supervision.
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April, 2004
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The Otter Auto-destruct Safety Syringe received
the United States Food and Drug Administration (FDA)
510(K) Pre-market Notification for admission into the
U.S. market.
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May, 2004
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Completion of the manufacturing facility in Wuxi, China.
Subsequently, Otter Medical was granted the License
for Medical Instruments Manufacturer.
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March, 2005
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Otter Medical obtained ISO 9001:2000 and ISO 13485:2003
Quality Management Systems Certifications.
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