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15th building, SMEs Venture Park

SongShan Lake Hi-Tech

Industrial Development Zone

Dongguan

523808

China

Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number CE 620265 Standard/scheme number or name 93/42/EEC Annex II, Sec 3.2 (2007/47) Start date 2015-04-07 Expiry date 2024-05-26
Scope
The Design and Manufacture of sterile, single use PTA and PTCA balloon dilatation catheters and Hydrophilic Guidewires.
Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number MD 647941 Standard/scheme number or name ISO 13485:2016 & EN ISO 13485 Start date 2016-08-22 Expiry date 2028-08-21
Scope
Design, manufacture and distribution of PTCA Coronary Balloon Dilatation Catheters, PTA Balloon Dilatation Catheters, Hydrophilic Guide Wires, Catheter Sheath Introducer, Accessories, Microcatheters, Neurovascular Catheters and Drug-Coated Balloon Dilatation Catheters. Manufacture of Neuromuscular Stimulation Devices and Accessories for medical purposes.
PTCA 冠脉球囊扩张导管、PTA外周球囊扩张导管、亲水导丝、导管鞘、配件、微导管、神经血管导管和药物涂层球囊扩张导管的设计、制造和销售。医疗用神经肌肉刺激器和配件的制造。
Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number CE 663700 Standard/scheme number or name 93/42/EEC, Annex II, Section 4 (2007/47) Start date 2017-09-13 Expiry date 2023-10-20
Scope
Artimes (Other brand names: Aperi SC, Origin SC) Balloon Dilatation Catheters
Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number CE 663704 Standard/scheme number or name 93/42/EEC, Annex II, Section 4 (2007/47) Start date 2017-09-13 Expiry date 2023-10-20
Scope
Apollo (Other brand names: Aperi NC, Origin NC) Balloon Dilatation Catheters
Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number MDR 752504 Standard/scheme number or name (EU) 2017/745 Annex IX Chapter I and III Start date 2023-03-10 Expiry date 2028-03-09
Scope
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Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number MDR 752505 Standard/scheme number or name (EU) 2017/745 Annex IX Chapter II Start date 2024-02-28 Expiry date 2029-02-27
Scope
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Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number MDR 752506 Standard/scheme number or name (EU) 2017/745 Annex IX Chapter II Start date 2024-02-28 Expiry date 2029-02-27
Scope
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Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number UKCA 772353 Standard/scheme number or name UK MDR Part II Annex II Sec 3.2 Start date 2023-04-12 Expiry date 2028-03-09
Scope
Design, manufacture and final inspection of sterile PTA and PTCA balloon dilatation catheters
Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number UKCA 772354 Standard/scheme number or name UK MDR Part II Annex II Sec 4 Start date 2024-04-15 Expiry date 2029-02-27
Scope
Artimes / Aperi SC / Origin SC Balloon Dilatation Catheters
Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number UKCA 772356 Standard/scheme number or name UK MDR Part II Annex II Sec 4 Start date 2024-04-15 Expiry date 2029-02-27
Scope
Apollo / Aperi NC / Origin NC Balloon Dilatation Catheters
Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number MDR 796971 Standard/scheme number or name (EU) 2017/745 Annex IX Chapter II Start date 2024-09-26 Expiry date 2029-09-25
Scope
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Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number MDR 796973 Standard/scheme number or name (EU) 2017/745 Annex IX Chapter II Start date 2024-09-26 Expiry date 2029-09-25
Scope
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Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number MDR 805974 Standard/scheme number or name (EU) 2017/745 Annex IX Chapter II Start date 2024-12-09 Expiry date 2029-12-08
Scope
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