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IV. Country Specific Market Clearance
United States: 510(k) number K020399 (OTC) and K000405 (Rx)
European Union: CE 0473
Israel: Ministry of Health number 237-0000
South Korea: Korean KFDA 04-259
Canada: Health Canada 63948
Thailand: ISR 4700595
China: SFDA 2260351
Manufacturer Authorized Representative in Europe:
MEDES Ltd.
9, Beaumont Gate, P.O.Box 231
Shenley Hill, Radlett, Hearts
London WD78BX, UK
tel/fax: +44 (0) 192 385 9810
email: medes@arazygroup.com
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