Athens, TX Full Quality Assurance Certificate

Product catalog summary

Certificate Overview:
This document is an EC Certificate for a Full Quality Assurance System issued to Argon Medical Devices, Inc., located in Athens, Texas, USA. The certificate, first issued on February 28, 2011, is valid until May 26, 2024, provided the quality system is maintained according to Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4. The certificate is issued by BSI Group The Netherlands B.V., a Notified Body.

Scope of Certification:
The certificate covers the design and manufacture of single-use instruments, catheters, access devices for intravascular and non-vascular applications, biopsy devices, fluid administration devices, thrombectomy devices, vena cava filter systems, and hemodialysis catheters. For Class III products, an additional Annex II section 4 certificate is required.

Device Classification and Intended Use:

Class III Devices: Includes Endomyocardial Biopsy Forceps, Stainless Steel and PTFE-Coated Stainless Steel Guidewires, and various catheters and snare kits.
Class IIb Devices: Includes PE Drainage Catheters and SKATER Drainage Catheters for various drainage applications, and Cleaner Rotational Thrombectomy Devices for mechanical declotting in peripheral vasculature.
Class IIa Devices: Includes Access Devices, Fluid Management Devices, and Biopsy Devices.

Certificate History:
The certificate history details various updates and changes, including the addition and removal of subcontractors, scope extensions, and administrative updates. Notable changes include the extension of scope to include thrombectomy devices and the removal of certain subcontractors.

Conditions and Contact Information:
The validity of the certificate is conditional on maintaining the quality system as per the directive requirements. The certificate excludes products designed or manufactured by third parties unless agreed with BSI. Contact information for BSI Group The Netherlands B.V. is provided for further inquiries.

Change of EU Authorised Representative Address:
Date: 29 February 2024
Action: Change of EU Authorised Representative address to Westervoortsedijk 60, 6827 AT Arnhem, The Netherlands.
Company: Argon Medical Devices, Inc., 1445 Flat Creek Road, Athens, Texas, USA
Context: The letter addresses the transitional provisions specified in MDR Article 120(3), which prohibit Notified Bodies from issuing new certificates or modifying existing MDD/AIMDD certificates after 26th May 2021.
Approval: BSI has reviewed and approved the change of address, confirming it does not represent a significant change in design or intended purpose under MDR Article 120(3) and MDCG 2020-3 guidance.
Certificate Details: CE 565719 under Directive 93/42/EEC Annex II excluding Section 4, with reference number 30114135.
Contact Information: For queries, contact BSI Scheme Manager, Graeme Tunbridge, Senior Vice President, Medical Devices, BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands. Phone: +31 20 346 0780, Email: [email protected]

Catalog excerpts

Athens, TX Full Quality Assurance Certificate-1

EC Certificate - Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 Supplementary Information to CE 565719 Issued To: No. Issued To: Argon Medical Devices, Inc. CE 565719 1445 Flat Creek Road Argon Medical Devices, Inc. Athens 1445 Flat Texas Creek Road 75751 Athens USA Texas The design and manufacture of single use instruments, catheters and access devices for intravascular and non-vascular applications, biopsy devices, fluid administration devices, thrombectomy devices, vena cava filter systems and hemodialysis catheters. 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 2797): Gary E Slack, Senior Vice President - Medical Devices First Issued: 2011-02-28 First Issued: 2011-02-28 Expiry Date: 2024-05-26 Expiry Date: 2024-05-26 Page 1 of 5 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. Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group of Companies.

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Athens, TX Full Quality Assurance Certificate-2

Quality Assurance System bsi.EC Certificate - Full Supplementary Information to CE 565719 Issued To: Argon Medical Devices, Inc. 1445 Flat Creek Road First Issued: 2011-02-28 Date: 2021-02-25 Expiry Date: 2024-05-26 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...

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Athens, TX Full Quality Assurance Certificate-3

Full Quality Assurance System Supplementary Information to CE 565719 Issued To: Argon Medical Devices, Inc. 1445 Flat Creek Road First Issued: 2011-02-28 Date: 2021-02-25 Expiry Date: 2024-05-26 ...making excellence a habit!" 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....

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Athens, TX Full Quality Assurance Certificate-4

Quality Assurance System Supplementary Information to CE 565719 Issued To: Argon Medical Devices, Inc. 1445 Flat Creek Road First Issued: 2011-02-28 Date: 2021-02-25 Expiry Date: 2024-05-26 ...making excellence a habit!" 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...

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Athens, TX Full Quality Assurance Certificate-6

bsi.EC Certificate - Full Quality Assurance System Certificate History Certificate No: CE 565719 Issued To: Argon Medical Devices, Inc. 1445 Flat Creek Road 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...

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Athens, TX Full Quality Assurance Certificate-8

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Athens, TX Full Quality Assurance Certificate

Athens, TX Full Quality Assurance Certificate

Catalog excerpts

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