1) Beijing Shark International Medical Sciences Co., Ltd. applied for an OTC certificate for their cigarette harm reduction cards. 2) The cards are models BS-1, BS-2, and BS-3, and are sold under the Blue Sea brand. 3) Based on their review, the certification body confirmed that the technical specifications for the cards meet the requirements of relevant European directives.

1. OTC
EUROPEAN COMMUNITY --- CERTIFICATE OF OTC
CERTIFICATE No:TC/10/1230/1027/CN
APPLICANT NAME: BEIJING SHARK INTERNATIONAL MEDICAL SCIENCES CO.,LTD
APPLICANT ADDRESS: RM.802,GOLDEN BAIZIWAN MARITIME CENTER BLOCK
A,BUILDING NO.402 ChAOYANG DISTRICT,BEIJING, CHINA
MANUFACTURER NAME: BEIJING SHARK INTERNATIONAL MEDICAL SCIENCES CO.,LTD
MANUFACTURER ADDRESS: RM.802,GOLDEN BAIZIWAN MARITIME CENTER BLOCK
A,BUILDING NO.402 ChAOYANG DISTRICT,BEIJING, CHINA
PRODUCT NAME: CIGARETTE HARM REDUCTION CARD
MODELS: BS-1(83mmx50mm) , BS-2(83mmx50mm) BS-3(83mmx50mm)
BRAND NAME: BLUE SEA
HARMONISATION
This product complies with the Safety regulations of the mite
Euro
pe
or
ISO13485:2003
nf
en
Co
Medical Devices
ne
-Quality Management Systems
-Requirements For Regulatory Purposes ap
REMARKS
proved
This Certificate Is Only Valid For The Equipment And Configuration Described, And In
Conjunction With The Test Data Detailed Above.
CONCLUSION OF ASSESSMENT
Based on our review we can confirm that the technical for the above mentioned product
meets the requirements of the relevant Directives
The manufacturer is responsibale for certifying the product and ensuring that all
. manufactured products are in compliance with the specifications detailed in the
construction file.
Certificate issued: Dec.30,2010
Place: Paris, France
Signature:
France Organization For Technical Conformity Center Ltd
22 Rue de Sevres,75007,Paris,France
info@global-otc.eu