Enhanced precision, flexibility and diversity. Incomparable quality of specialty needles recognized worldwide. A leader in the specialty needle field, Unisis Corporation
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Quality Policy
Quality Policy
UNISIS is committed to provide safe and high-qualityproducts and reliable services to customers all over the world.
License, registration, and accreditation
| 1989/10 | Obtained import license for medical devices in Japan (BBY6379 for the Tokyo office) |
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| 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 Tﾃ弖 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 Tﾃ弖 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 Tﾃ弖 Rheinland |
| 2005/12 | Obtained CE marking audited by Tﾃ弖 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 |
| 2019/02 | Obtained CE marking for Atraumatic Microneedle audited by SGS |