Certificates
Sonova’s devices are regulated by government agencies, healthcare authorities, and other regulatory bodies worldwide. These organizations verify that throughout the life cycle of our products we are fulfilling the requirements of applicable health and safety regulations. We are committed to maintaining transparent, constructive, and professional relationships with all applicable regulatory authorities on policy, product submissions, compliance, and product performance. Each national healthcare authority has specific requirements for products that are offered in its market which need to be respected. Find here the full text of theRadio Equipment Directive 2014/53/EU Declaration of Conformity.
Radio Equipment Directive 2014/53/EU Declaration of Conformity
- QDL-108 [7] ISO 90012015 Certificate no.35403 rev.6 Sonova AG
- QDL-109 [11] ISO 134852016 Certificate no.32433 rev. 11 Sonova AG
- QDL-291 [12] MDR DoC Phonak Audéo P-13T
- QDL-1261 [8] MDR DoC Virto P
- QDL-1478 [9] MDR DoC Phonak Audéo L_ampli-energy R L R PH
- QDL-1479 [7] MDR DoC Phonak CROS L
- QDL-1616 [11] MDR DoC uMozart4 ITE
- QDL-1801 [2] MDR DoC uMozart4 ITE HANSATON
- QDL-1973 [3] MDR DoC Phonak Slim L-R
- QDL-2247 [14] MDR DoC uPrince1
- QDL-2420 [5] MDR DoC Phonak Naida L-UP Naida L-PR Terra BTE-UP
- QDL-2421 [3] MDR DoC Phonak Sky L
- QDL-2636 [3] MDR DoC Cali 1.5 and Cali 2.5
- QDL-2756 [10] MDR DoC uPrince2 & uPrince3
- QDL-3126 [4] MDR DoC Phonak Audéo L-312 Phonak Terra RIC
- QDL-3141 [4] MDR DoC Phonak Naída L-SP Sky L-SP Terra BTE-SP
- QDL-3142 [4] MDR DoC Phonak Sky L-M Terra BTE-M_Terra
- QDL-3390 [5] MDR DoC Phonak Lyric4 (Tenor)
- QDL-3683 [6] MDR DoC Phonak Audéo I-Sphere
- QDL-3684 [6] MDR DoC Phonak Audéo I-R
- QDL-3685 [5] MDR DoC Sennheiser Sonite R
- QDL-3686 [6] MDR DoC CROS I-R
- QDL-3705 [6] MDR DoC Virto I- NW_ampli mini I_Virto I-R
- QDL-3841 [6] MDR DoC uGround1 RIC
- QDL-3966 [2] MDR DoC Naida L-M
- QDL-3967 [2] MDR DoC Phonak Naida Link L Phonak Sky Link L
- QDL-4296 [3]MDR DoC Phonak Terra+ RIC-R
- QDL-4415 [5] MDR DoC uAmy1
- QDL-4495 [2] MDR DoC Naida Link M_Sky Link M
- QDL-5577 [4] MDR DoC uAmy2 ITE