Declaration of Conformity
Manufacturer: Shenzhen Carewell Electronics Co., Ltd.
Manufacturer Address:
Floor 4, BLO 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street,Nanshan District
518108, Shenzhen, PR. China
Facility Address:
Floor 4, BLD 9, Balwangxin High-Tech Industrial Park, Songbai Road, Xili Street,Nanshan District
518108, Shenzhen, PR. China
European Representative: Lepu Medical (Europe) Cooperatief UA.
Address: De Marne 118, 8701 MC Bolsward, The Netheriands
Product: Electrocardiograph
Model: ECG-1101B, ECG-1101C, ECG-1101G,
ECG-1101B( I), ECG-1101C( 1), ECG-1101G( 1),
ECG-1103B, ECG-1103G, ECG-1103L, ECG-1103LW, ECG-11036W,
ECG-1103B( 1 ), ECG-1103G( I ), ECG-1103L( I ), ECG-1103LW( 1 ), ECG-1103GW( I).
ECG-1106L, ECG-1106G, PCECG-500(ECG workstation)
ECG-1112, ECG-1112L, ECG-1112M, ECG-1112D, 112
Main Accessory: ECG Cable, ECG Electrode
Classification (MDD, Annex IX): _ Ila (According to MDD, Rule 10)
Conformity Assessment Route: Annex V3
We herewith deciare that the above-mentioned products meet the provisions of the following EC
Council Directives and Standards. All supporting documentations are retained under the premises of
the manufacturer.
DIRECTIVES
General Applicable Directives:
Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC concerning medical devices (MDD
93/42/EEC) and its amended Directive 2007/47/EC.
Notified Body: TUV SUD Product Service GmbH
Address: Ridlerstrasse 65, 80339 Munich, Germany
Certificate No.: G1 050440 0031 Rev.00
The Certificate is valid until: 2024-05:26
Place, Date of issue: Shenzhen, 2019-11-14 Signature:
Name:
Date:
Position: Shenchen Caewell lecwonies Co, Ltd
carewell arson Dist 51108, techn, PR Chia
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Tel $8647
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8617 0389, Fax +86-755-8617 0978
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Declaration of Identical Construction
October 8" 2019
We Shenzhen Carewell Electronic Co.,Ltd,
Located in Floor 3, BLD9, Baiwangxin High-Tech Industrial Paark, Songbai Road , Xili
Street, Nanshan District, Shenzhen, China.
Hereby declare the following Kalamed Products
Model: KES-301; KES-301T; KES-601T & KES-121T
Are identical with Cert
1d Shenzhen Carewell Electronic Co.,Ltd's devices
Model: 1103G; 1103L; 1106L & 1112M.
