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Quality Policy

UNISIS is committed to provide safe and high-qualityproducts and reliable services to customers all over the world.

Quality Policy

UNISIS is committed to provide safe and high-qualityproducts and reliable services to customers all over the world.

Priority Policy

License, registration, and accreditation

1989/10 Obtained import license for medical devices in Japan
(BBY6379 for the Tokyo office)
1994/2 Obtained manufacturing license for medical devices
(11BZ0588 for the Koshigaya factory)
1995/11 Obtained Japanese accreditation in Good Manufacturing Practices
(GMP)
1996/09 US Food and Drug Administration registration
(FDA Facility Registration No. 9014974/USA)
1997/06 Obtained accreditation of ISO9002/ISO13488 audited by TÜV Rheinland
1999/01 Obtained license for manufacturing veterinary appliances
(16 veterinary manufacturer No.344 for Koshigaya factory)
2003/06 Obtained accreditation of ISO9001/ISO13488 audited by TÜV Rheinland
2004/01 Obtained manufacturing license for medical devices
(11BZ6041 for Saitama Plant)
Obtained manufacturing license for veterinary appliances
(16 veterinary manufacturer No. 457 for Saitama factory)
2004/07 Obtained accreditation of ISO9001/ISO13485 audited by TÜV Rheinland
2005/12 Obtained CE marking audited by TÜV Rheinland
2009/07 Obtained Medical Device Manufacturer Permit
(11BZ200120:at Logistics/sterilization center
2010/06 Renewed CE marking that covers spinal needles, a Class III device
2011/01 Notified Body for ISO9001/ISO13485 registration changed to SGS
2012/05 Notified Body for CE Marking (EU) registration changed to SGS
2014/10 Obtained 510(k) clearance for Spinal Anesthesia Needle
2015/01 Obtained 510(k) clearance for Epidural Anesthesia Needle and Nerve Blockade Needle