EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4
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1 No. CE In respect of: The design and manufacture of single use instruments, catheters and access devices for intravascular and non-vascular applications, biopsy devices, fluid administration and pressure monitoring devices on the basis of our examination of the quality assurance system under the requirements of Council Directive 93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For the placing on the market of class III products an Annex II section 4 certificate is required. For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 0086): Gary Fenton, Global Assurance Director First Issued: 28/02/2011 Date: 19/02/2014 Expiry Date: 01/12/2017 Page 1 of 1 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract.
2 Becton Dickinson Infusion Therapy Systems, Inc South State Street Sandy Utah Argon Critical Care Systems Singapore Pte. Ltd. 198 Yishun Avenue 7 Singapore Singapore Shanghai Greenway Medical Apparatus Co., Ltd. (Supplied through International Medsurg Connection) No. 3899, Puxing Road Shanghai China Control of Sterilization Packaging ETO Sterilization Packaging Page 1 of 6
3 Ningbo Shengyurui Medical Appliances Co., Ltd. (Supplied through International Medsurg Connection) No. 138, Binhaisi Road, Hangzhou Bay New Zone Cixi City, Zhejiang Province China Emergo Europe Molenstraat BH The Hague Netherlands Medron, Inc South Gladiola St. Salt Lake City Utah Greatbatch Medical 2300 Berkshire Lane North Minneapolis Minnesota B. Braun Medical, Inc. 824 Twelfth Avenue Bethlehem Pennsylvania EU Representative Page 2 of 6
4 M/s Ribbel International Ltd. (Supplied through International Medsurg Connection) 20th Mile G.T. Road, Jatheri Road P.O. RAI Sonepat Haryana India Martech Medical Products, Inc Delp Drive Harleysville Pennsylvania Aspen Surgical Puerto Rico Corp. Road 183, KM 20.3 Las Piedras Puerto Rico Accellent, Inc. 45 Lexington Laconia New Hampshire Lemco Enterprises P.O. Box Hale Road Ardmore Oklahoma ETO Sterilization Page 3 of 6
5 Halkey-Roberts Corp Halkey-Roberts Place N St. Petersburg FL Rex Medical, L.P East Hector Street, Suite 245 Conshohocken PA Aspen Surgical Products, Inc Southbelt Drive, SE Caledonia Michigan Becton Dickinson Infusion Therapy Systems, Inc. S.A. de C.V. Periferico L. D. Colosio #579 Nogales, Sonora C.P Mexico 3M Health Care dba 3M Consumer Health Care 3M Center, Building 275 St Paul Minnesota Design Control of Sterilization Packaging Page 4 of 6
6 Wenzhou KLF Medical Plastics Co., Ltd. (Supplied through International Medsurg Connection) No. 258, Tongqiang West Road Wenzhou China Synergy Health AST, LLC 500 West 4th Street Lima OH Manan Medical Products Inc also dba Angiotech 241 W. Palantine Road Wheeling Illinois Sterigenics US, LLC 1302 Avenue T Grand Prairie E beam Sterilization ETO Sterilization Page 5 of 6
7 Pelham Plastics Inc 42 Dick Tracy Drive P.O. Box 997 Pelham New Hampshire STERIS Isomedix Services 2072 Isomedix Services Spartanburg South California ETO Sterilization Page 6 of 6
8 Certificate History Date Reference Number Action 28 February First Issue - Transfer from another Notified Body 11 October January August October February "Also trading as Becton Dickinson " added to the manufacture name. Becton Dickinson Infusion Therapy Systems, Inc. S.A. de C.V., Becton Dickinson Infusion Therapy Systems, Inc., Argon Critical Care Systems Singapore Pte. Ltd. and B.Braun Medical Inc. added to the list of significant subcontractors. 3M Health Care, Aspen Surgical Products, Medron, Greatbatch Medical and Martech Medical Products added to the list of significant subcontractors. Rex Medical, Aspen Surgical Puerto Rico and Halkey-Roberts added to the list of significant subcontractors. Certificate Renewal. Address change for Ningbo Shengyurui Medical Appliances and M/s Ribbel International. Scope extension to include biopsy devices and access devices for non-vascular applications. List of subcontractors updated to include the significant suppliers involved in the manufacturing of the new products. Page 1 of 1 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and is bound by the conditions of the contract.
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