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)
ArgentinaApproved
AustraliaApproved
(distributors should contact HIMSA for more information)
BoliviaApproved
BrazilApproved To obtain the Anatel certificate – write to HIMSA@himsa.dk
CanadaApproved
ChileApproved
ChinaApproved
ColumbiaApproved
Costa RicaApproved
EAEU (Kazakhstan, Belarus, Armenia, Kyrgyzstan)in process (2024-August-14)
Ecuadorin process (2024-August-12)
Egyptin process (2024-Sept-4)
Europe (EU)Approved
Guatemalain process (2024-August-19)
Hong KongApproved
IndiaApproved
Indonesia ON HOLD Until an importer is found. Contact HIMSA if you wish to import.
IsraelApproved
JapanApproved
Malaysiain process (2024-August-22)
Mexicoin process (2024-July-19)
New ZealandApproved
(distributors should contact HIMSA for more information)
Omanin process (2024-July-26)
Pakistanin process (2024-August-16)
PanamaApproved
PeruApproved
PhilippinesApproved
QatarApproved
SerbiaApproved
SingaporeApproved
South AfricaApproved
South KoreaApproved
SwitzerlandApproved
(covered by CE certification)
Taiwanin process (2024-June-21)
ThailandApproved
TurkeyApproved
(covered by CE certification)(distributors will need to apply for an import permission to the Undersecretariat of Foreign Trade)
UkraineApproved Approved
United KingdomApproved
Uruguayin process (2024-September-2)
USAApproved Approved
Vietnamno approval necessary