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 Declarations

Certificate NameDownload
Bluetooth Host Subsystem Link
Bluetooth Controller Subsystem Link

Declaration of Conformity

Certificate NameDownload
RED, 2014/53/EULink

Country Approvals

CountryStatus (Expected date)
Argentinain process (2024-05-09)
(distributors should contact HIMSA for more information)
Boliviain process (2024-06-11)

To obtain the Anatel certificate – write to
Chilein process (2024-06-22)
Chinain process (2024-05-8)
[Changed from 04-19]
Costa RicaApproved
EAEU (Kazakhstan, Belarus, Armenia, Kyrgyzstan)in process
Europe (EU)Approved
Hong KongApproved
Indonesia in process ON HOLD
Until an importer is found. Contact HIMSA if you wish to import.
Malaysiain process – ON HOLD
Until an importer is found. Contact HIMSA if you wish to import.
Mexicoin process
New ZealandApproved
(distributors should contact HIMSA for more information)
Panamain process (2024-06-6)
Peruin process (2024-06-14)
Philippinesin process (2024-05-23)
South Africain process (2024-06-28)
South KoreaApproved
(covered by CE certification)
Taiwanin process (2024-04-18)
(covered by CE certification)(distributors will need to apply for an import permission to the Undersecretariat of Foreign Trade)
Ukrainein process (2024-05-16)
United KingdomApproved
USAApproved Approved
Vietnamno approval necessary