General Information
| Registered Name: |
FUKUDA SANGYO INC. |
| Postal and Communications Details: |
# 8 Gertrudes Street, Mambugan, Antipolo City 1870, Philippines (manufacturing site) Tel & Fax No: +(632) 645-8276 +(632) 646-6576 (e-mail address) |
| President: | Geraldo S. Sadian |
| QMS Certified Conformity: | EN ISO 13485:2003 valid until 31 July 2006; and, Annex V of EC Directive 93/42/EEC on Medical Devices valid until 9 March 2010. |
| Facility Area: | 248 m2 (2,669.45 ft2) office area; and, 362 m2 (3,896.54 ft2) production area. The existing facility is a fully dedicated factory set in a sprawling 1000 m2 site. As per local zoning, our area is a designated industrial zone of about 5000 m2. Across the street is an area for commercial purposes. There is however no existing industrial operator beside us in view of our right for first refusal on the adjoining lots. |
Our Mission
At Fukuda Sangyo, we seek to be the leading producer of Pulmonary Function Test (PFT) instruments by providing society and the industry products with excellent features and functions.
Historical Events
Fukuda Sangyo Inc., coined as FSI, was incorporated 16 August 1991 and thereon began its administrative function with a Philippine charter that is authorized under a pioneering status to engage in the manufacture, assembly, sale, and trade of various pulmonary function equipment and other allied products.
On 23 September 1991, formal production operation was started on a rented office space of 144 m2 in Antipolo, Rizal – Philippines. From that time on, FSI has steadily occupied itself with assembly activities of various electronic pulmonary function testing equipment, particularly spirometers. The technology being passed on to us by Fukuda Sangyo Co. Ltd., a Japanese company also engaged in the production and trading of various electronic medical equipment since the late 50’s. Bringing in their technological resources to facilitate the technology transfer.
With the production expertise in place and at that time staffed and manually equipped for a production capacity of 100 units per month, the first batch of spirometer products, the ST-250 Spiroanalyzer was dispatched on 26 December 1991 bound for the Japanese market. Followed by the ST-90 Spiroanalyzer where the first shipment was made on 16 January 1993 also for the Japanese market. Later on with the help of a US-based trading company for an FDA 510K product certification, we then commenced shipments of the ST-250 and ST-90 Spiroanalyzers to the US on 18 August 1993 and 4 September 1993 respectively. And on 20 September 1995, our production activity also included the ST-95 Spiroanalyzer product mainly exported to Japan. The same model was later also exported to Europe with our infancy shipment on 27 June 1997. The above models before outdating their full market life had actually provided us the impetus to stay in brisk business.
Through foresight and seeing that third-party production certification emerging as a requirement, FSI then embarked during the middle months of 1997 at having its production facility certified to ISO 9002:1994. But later found that additional certifications are also required. As testament to our commitment to quality, we then set out on the adoption of a Quality Management System (QMS) in line with the required standards and on 10 December 1999, an audit conducted by TUV Product Service gave us the conditional approval. With FSI finally getting its certification to standards ISO 9002:1994, EN 46002:1996 and Annex V of the MDD 93/42/EEC effective 3 April 2000. Amid the latest change in certification standards, FSI then on 25 May 2004 was later certified to the stand-alone standards for medical devices manufacturers, the ISO 13485:2003. Together with our earlier certification for Annex V of MDD 93/42/EEC all still certified by TUV Product Service.
By about the same time during our certification preparation, FSI has also seen the requirements for more production space and perhaps automated and faster assembly equipment. Sometime in the year 2001, FSI decided to acquire a piece of land to build its own facility. The building that now houses our current office and factory was finally completed and therein occupied by us on 1 March 2002. The new facility now boasts of about 620 m2 of space. Enough space to host our automated SMT Assembly and Reflow Oven equipment that arrived on site 24 April 2002 and later commissioned for use on about June 2002.
It was in this new production equipment that the ST-75 SpiroAnalyzer will be built for export again to Japan and Europe. Completed ST-75 Assembly parts started rolling out the new FSI facility on 14 November 2003 and completed units were first dispatched to Europe on 3 September 2004. Consequently, assembly parts for the Bilimeter also began production and the first shipment was made on 28 October 2003. Further utilizing our facility, the assembly parts for another Japanese spirometer model, the SP-350 SpiroAnalyzer was also assigned and a first shipment made on 9 September 2004.
To infuse enthusiasm and technological self-esteem, we have consistently thought of embarking on applied research and development for our future products. Early on, our participation was confined to product differentiation and improvement exercises. By figuring prominently in the improvement of our current line of spirometers. Our first project was the TSS97 spirometer that later on became the ST-75 Spiroanalyzer. Wherein our primary task was to develop the hardware schematics and software subsystems of the prospective product. In this project, the actual work was undertaken by an assigned subcontractor working under our tutelage. The project after some considerable accomplishment on May 2003 was then turned over to Fukuda Sangyo Co. Ltd. for its business implementation. After the TSS97 (or ST-75 Spiroanalyzer) stint, FSI then proceeded in putting up its own R&D staff with the ST-150 SpiroAnalyzer as our immediate project. Current projects are simulataneously on the pipeline with the the ST-150 product due for distribution.
On 23 September 1991, formal production operation was started on a rented office space of 144 m2 in Antipolo, Rizal – Philippines. From that time on, FSI has steadily occupied itself with assembly activities of various electronic pulmonary function testing equipment, particularly spirometers. The technology being passed on to us by Fukuda Sangyo Co. Ltd., a Japanese company also engaged in the production and trading of various electronic medical equipment since the late 50’s. Bringing in their technological resources to facilitate the technology transfer.
With the production expertise in place and at that time staffed and manually equipped for a production capacity of 100 units per month, the first batch of spirometer products, the ST-250 Spiroanalyzer was dispatched on 26 December 1991 bound for the Japanese market. Followed by the ST-90 Spiroanalyzer where the first shipment was made on 16 January 1993 also for the Japanese market. Later on with the help of a US-based trading company for an FDA 510K product certification, we then commenced shipments of the ST-250 and ST-90 Spiroanalyzers to the US on 18 August 1993 and 4 September 1993 respectively. And on 20 September 1995, our production activity also included the ST-95 Spiroanalyzer product mainly exported to Japan. The same model was later also exported to Europe with our infancy shipment on 27 June 1997. The above models before outdating their full market life had actually provided us the impetus to stay in brisk business.
Through foresight and seeing that third-party production certification emerging as a requirement, FSI then embarked during the middle months of 1997 at having its production facility certified to ISO 9002:1994. But later found that additional certifications are also required. As testament to our commitment to quality, we then set out on the adoption of a Quality Management System (QMS) in line with the required standards and on 10 December 1999, an audit conducted by TUV Product Service gave us the conditional approval. With FSI finally getting its certification to standards ISO 9002:1994, EN 46002:1996 and Annex V of the MDD 93/42/EEC effective 3 April 2000. Amid the latest change in certification standards, FSI then on 25 May 2004 was later certified to the stand-alone standards for medical devices manufacturers, the ISO 13485:2003. Together with our earlier certification for Annex V of MDD 93/42/EEC all still certified by TUV Product Service.
By about the same time during our certification preparation, FSI has also seen the requirements for more production space and perhaps automated and faster assembly equipment. Sometime in the year 2001, FSI decided to acquire a piece of land to build its own facility. The building that now houses our current office and factory was finally completed and therein occupied by us on 1 March 2002. The new facility now boasts of about 620 m2 of space. Enough space to host our automated SMT Assembly and Reflow Oven equipment that arrived on site 24 April 2002 and later commissioned for use on about June 2002.
It was in this new production equipment that the ST-75 SpiroAnalyzer will be built for export again to Japan and Europe. Completed ST-75 Assembly parts started rolling out the new FSI facility on 14 November 2003 and completed units were first dispatched to Europe on 3 September 2004. Consequently, assembly parts for the Bilimeter also began production and the first shipment was made on 28 October 2003. Further utilizing our facility, the assembly parts for another Japanese spirometer model, the SP-350 SpiroAnalyzer was also assigned and a first shipment made on 9 September 2004.
To infuse enthusiasm and technological self-esteem, we have consistently thought of embarking on applied research and development for our future products. Early on, our participation was confined to product differentiation and improvement exercises. By figuring prominently in the improvement of our current line of spirometers. Our first project was the TSS97 spirometer that later on became the ST-75 Spiroanalyzer. Wherein our primary task was to develop the hardware schematics and software subsystems of the prospective product. In this project, the actual work was undertaken by an assigned subcontractor working under our tutelage. The project after some considerable accomplishment on May 2003 was then turned over to Fukuda Sangyo Co. Ltd. for its business implementation. After the TSS97 (or ST-75 Spiroanalyzer) stint, FSI then proceeded in putting up its own R&D staff with the ST-150 SpiroAnalyzer as our immediate project. Current projects are simulataneously on the pipeline with the the ST-150 product due for distribution.