The following tables contains pdfs of Certificates and Test Reports for Noahlink Wireless 2:
This page will be updated as Noahlink Wireless 2 certificates and approvals become available.
Important: If you have countries that should be prioritized, please let HIMSA know via HIMSA@HIMSA.DK.
Important: Noahlink Wireless 2 is not classified as a medical device and therefore does not need to follow medical device regulations. The Harmonized System (HS) code is: 85176200 (CN).
Bluetooth Qualified Product Details
| Product Name | Download |
|---|---|
| Noahlink Wireless 2 | Link |
Declaration of Conformity
| Certificate Name | Download |
|---|---|
| RED, 2014/53/EU | Link |
Country Approvals
| Country | Status (Expected date) |
|---|---|
| Albania | Covered by CE approval |
| Algeria | Pending |
| Argentina | Approved |
| Australia | Approved (distributors should contact HIMSA for more information) |
| Azerbaijan | Approved |
| Bahrain | Approved |
| Bangladesh | Pending |
| Bolivia | Approved |
| Bosnia-Herzegovina | covered by CE approval |
| Brazil | Approved To obtain the Anatel certificate – write to HIMSA@himsa.dk |
| Canada | Approved |
| Chile | Approved |
| China | Approved |
| Columbia | Approved |
| Costa Rica | Approved |
| Cuba | Pending |
| Dominican Republic | Approved |
| EAEU (Kazakhstan, Belarus, Armenia, Kyrgyzstan) | Approved |
| Ecuador | Approved |
| Egypt | Pending |
| El Salvador | no approval necessary |
| Europe (EU) | Approved |
| Fiji | Approved |
| Georgia | Covered by CE approval |
| Guatemala | Approved |
| Honduras | Approved |
| Hong Kong | Approved |
| India | Approved |
| Indonesia | Approved |
| Iraq | Pending |
| Israel | Approved |
| Japan | Approved |
| Jordan | Approved |
| Kosovo | no approval necessary |
| Kuwait | Approved |
| Lebanon | Approved |
| Libya | Approved |
| Macau | no approval necessary |
| Malaysia | Approved |
| Mexico | Approved |
| Namibia | no approval necessary |
| Moldova | no approval necessary |
| Mongolia | Approved |
| Morocco | Approved |
| Nepal | no approval necessary |
| New Zealand | Approved (distributors should contact HIMSA for more information) |
| North Macedonia | Covered by CE approval |
| Oman | Approved |
| Pakistan | Approved |
| Palestine | Approved Gaza Approved West Bank |
| Panama | Approved |
| Papua New Guinea | Approved |
| Paraguay | Pending |
| Peru | Approved |
| Philippines | Approved |
| Qatar | Approved |
| Saudi Arabia | distributors should contact HIMSA for more information |
| Serbia | Approved |
| Singapore | Approved |
| South Africa | Approved |
| South Korea | Approved |
| Sri Lanka | Pending |
| Sudan | Pending |
| Switzerland | covered by CE approval |
| Syria | Pending |
| Taiwan | Approved |
| Thailand | Approved |
| Tunisia | Approved |
| Turkey | covered by CE approval (distributors will need to apply for an import permission to the Undersecretariat of Foreign Trade) |
| Turkmenistan | Pending |
| UAE | Approved |
| Ukraine | Approved Approved |
| United Kingdom | Approved |
| Uruguay | Approved |
| USA | Approved Approved |
| Uzbekistan | Approved |
| Venezuela | Approved |
| Vietnam | no approval necessary |
HIMSA