 XXX Co., Ltd.
Address：XXX China
 Wellkang Ltd
Suite B,29 Harley Street London W1g 9QR, England United Kingdom
Product ：Wireless Probe Type Ultrasound Scanner（UProbe-L、UProbe-C、BProbe）
Classification - Annex IX: Class IIa, Rule10
Conformity assessment Route: Annex II(Exclude section 4 )
Registration NO. XXX
Valid from: 2018-08-30 Valid until: 2022-06-21 |
The declaration of conformity XXX Co., Ltd.:
We, the manufacturer, herewith declare that the stated medical devices meet the transposition International laws and regulations, the provisions of Council Directive 93/42/EEC of 14 june 1993 concerning medical devices;
Including, at 21 march 2010, the amendments by Council Directive 2007/47/EEC.
All supporting documentation is retained at the premises of the manufacturer.
The manufacturer is exclusively responsible for the declaration of conformity. |
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Standards applied: EN ISO 13485:2016 , IEC60601-1:2005+A1:2012, EN 60601-1-2:2007, EN60601-1-6:2010, EN 60601-2-37:2007+A1:2015, EN ISO 14971:2012, EN ISO 14155:2011, EN ISO 10993-1:2009, EN ISO 10993-5:2009, EN ISO 10993-10:2010, EN 62366:2008, EN 62304:2006, ISO 15223-1：2012, EN 1041:2008, MDDEV 2.12-1 rev 8, MEDDEV 2.12/2 rev2 |
Notified Body: TÜV SÜD Product service GmbH Ridlerstr 65, D-80339 München, Germany
identification number：  0123 |
Start of CE-marking:2018.8.30
Place, Date of Declaration: XXX,CHINA 2021-XXX-XXX
Signature:
name:XXX
position：General manager
position: XXX China
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