Approvals

European Union

Approval for the EU according to directive 93/42/EWG regarding medical devices (MDD)

English version | German version

 

EN ISO 13485-Certificate

English version | German version

 

Canada

Licence Scope
66278 “acupuncture needles”: asiamed Standard, Special, Special+, Gold, Silver, Apex & Apex Gold as well as s|needle B- and J-type
80916 “TeWa acupuncture needles”: with copper loop handle (C-type), plastic handle (P-type), spring handle (K-type) or with metal pipe handle (J-type) as well as Speed Pak
80917 “TeWa acupuncture needle with guide tube”: with guide tube (xJ-type) and with Safe-T Sleeve
80918 “TeWa acupuncture needle – intradermal needle”: ID-type

 

United States

510(k) Scope
K011808 asiamed Standard, Special, Compact, Apex
K031716 asiamed Special+, s|needle B-type und J-type
K042063 s|needle Press Tack Needle
K132896 TeWa acupuncture needles