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- On April 15th, 2005 and April 5th, 2005 the Shanghai factory and Suzhou factory acquired ISO13485 certification from the TUV Product Service GmbH in Germany.
ISO13485 requires a standard based on ISO 9001, a quality management system standard for medical equipment.
As a result of an amendment to the Medicine Act that went into effect in April 2005, Japanese Pharmacopoeia gauze and absorbent cotton pharmacologic products have been categorized as medical gauze and
absorbent cotton. Although applicable only vaguely to medical gauze and absorbent cotton, the changes to the Medicine Act have since been voluntary recognized nationwide. We have acquired ISO13485 to
ensure that our products adhere to these recent changes and follow the highest standards in the medical community.
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| Outline
of ISO13485 of Suzuran Shanghai factory in China |
| 1．Accreditation Organization |
America ANSI-RAB American National Standards
Institute |
| 2．Certification Organization |
Germany TUV Product Service GmbH |
| 3．Certificate No. |
Certificate No:Q1N050355089001 |
| 4．Date of Grant |
April 15th, 2005 |
| 5．Address |
Yue Luo Road 314, Baoshan District, Shanghai, China |
| 6．Cognizance |
Design and Development, Production and Distribution of Medical Gauze, Medical Sterilize Gauze Products, Bandage, Mask |
|
| Outline
of ISO13485 of Suzuran Suzhou factory in China |
| 1．Accreditation Organization |
America ANSI-RAB American National Standards
Institute |
| 2．Certification Organization |
Germany TUV Product Service GmbH |
| 3．Certificate No. |
Certificate No: Q1N050355090001 |
| 4．Date of Grant |
April 5th, 2005 |
| 5．Address |
Liu He Town, Tai Cang City, Jiang Su, China |
| 6．Cognizance |
Design and development, Production and Distribution of Medical Absorbent Cotton, Medical Gauze, Medical cotton Ball, Alcohol Cotton, Medical Non-woven and Related Product |
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