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.

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...

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....

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...

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...

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...

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...

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...