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FLOTEC |
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| 7625 West New York Street | ||
| Indianapolis, Indiana 46214-4911 USA | ||
| Telephone: (317) 273-6960 | ||
| Facsimile: (317) 273-6979 | ||
| Order Desk Telephone: (800) 401-1723 | ||
| Order Desk Facsimile: (800) 515-9254 | ||
| E-mail: info@floteco2.com | ||
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Certificates & Licenses |
| Australian GMDN Code: 31283 - Flowmeter, Gas Calibration, Manufacturer's Declaration of Conformity |
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Australian GMDN Code: 35300 - Regulator, Gas High-Pressure, Manufacturer's Declaration of Conformity |
| Australian GMDN Code: 37132 - Flowmeter, Oxygen Therapy, Manufacturer's Declaration of Conformity |
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Australian Register of Therapeutic Goods - 37132 Flowmeter, Oxygen Therapy, Certificate for Inclusion of a Medical Device |
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Australian Therapeutic Goods Administration & Health Canada Mutual Recognition of Medical Device QMS Certificates |
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Canadian Medical Device License: 8347 - Oxygen Regulator (Select License Number and type 8347 in search field) |
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Canadian Medical Device License: 28175 - Flowmeter (Select License Number and type 28175 in search field) |
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Canadian Medical Device License: 28176 - Oxygen Conserving Regulator (Select License Number and type 28176 in search field) |
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Canadian Medical Device License: 73462 - Integrated Valve Regulator (Select License Number and type 73462 in search field) |
| CE Certificate - Full Quality Assurance CE mark 0086 (C-CE Certificate(2009-10-28a).pdf) |
| CE Certificate - List of Significant Subcontractors (C-CE Certificate(2009-10-28b).pdf) |
| CE Certificate - History of Quality Assurance Certificate (C-CE Certificate(2009-10-28c).pdf) |
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FDA Establishment Listing for Flotec, Inc. - Establishment Registration Datab (ase at Center for Devices and Radiological Health |
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FDA Annual Registration - Subpart B--Procedures for Device Establishments, Part 807 -- Establishment Registration and Device Listing for Manufacturers |
| FDA Certificate to Foreign Government - List of Products that maybe Legally Marketed and Exported from the United States |
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FDA European and Canadian Device Classification Cross Reference - Dated 08-12-09, List of Flotec products with cross reference information between the: Code of Federal Regulation, Section 21; European Commision Meddev 2.4/1 Rev 8, Part 2, Rule 11 (Directive 93/42/EEC; Health Canada CAN/CSA-Z305 87M, Part 1, Rule 9 |
| FDA Small Business Qualification Certificate - Small Business Decision Number SBD0107114 |
| ISO 9001:2008 - BSI Certificate of Registration (C-ISO_9001:2008(2009-12-14).pdf) |
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ISO 13485:2003 - BSI Certificate of Registration (C-ISO_13485:2003(2009-12-14).pdf) |
| ISO Declaration of Conformity - Flotec Inc declares that the products listed has been classified as Class IIb - Annex IX, Rule 11 and is in conformity with the essential requirements and provisions of Council Directive 93/42/EEC (C-ISO Declaration of Comformity(2009-10-28).pdf) |
| European Authorized Representative - Contact Information for Flotec Authorized Representative |
| Japanese Medical Device License: BG30400412 - Japanese Medical Device QMS, Ministerial Ordinance No. 169, December 17, 2004 |
| Japanese Quality Agreement - Japanese Ministry of Health, Labour and Welfare Agreement entered into by Flotec and the Marketing Authorization Holder |
| US/Canada Joint Military Critical Techinical Data Agreement - US/Canada Joint Certification Program |