Question 1

What types of medical devices does WSAUD A/S manufacture?

Accepted Answer

WSAUD A/S manufactures hearing aids, including rechargeable and battery-powered models. Their product line includes the HA MOJO series, which features various case colors and battery types, as well as smaller, discreet hearing instruments like the S_ITE ACTIVE MINI. These devices are designed to address hearing loss with customizable and compact solutions.

Question 2

Where is WSAUD A/S based?

Accepted Answer

WSAUD A/S is based in Denmark (DK). The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.

Question 3

Which regulatory registries list WSAUD A/S’s devices?

Accepted Answer

WSAUD A/S’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This ensures transparency and compliance with EU medical device regulations.

Question 4

How are WSAUD A/S’s hearing aids classified under EU regulations?

Accepted Answer

WSAUD A/S’s hearing aids fall under EU medical device classifications Class I and Class IIa. The classification depends on factors like risk level, intended use, and design—Class I devices are generally low-risk, while Class IIa devices involve slightly higher risks and require additional scrutiny. The specific classification for each model is determined by its design and potential health impact.

Device	Model / Reference	Registries	Class	Status
Set Cros R Li 7 Gr	21006598	EUDAMED	Class IIa	Active
S_ite Amplienergyi55wrl Blk Blk	21031374	EUDAMED	Class IIa	Active
Ha Bicore B Hp 80 Bg	21040780	EUDAMED	Class IIa	Active
Kit Styletto 7ax Uk Cos Slv	21003312	EUDAMEDFDA UDI	Class IIa	Active
Ha Ab Horizon 3ax Ric-R Sb	21012953	EUDAMED	Class IIa	Active
Ha Ic 8 Ric Li G7 Blk	21010839	EUDAMED	Class IIa	Active
Ha R S 7.16 Slv	21002418	EUDAMED	Class IIa	Active
Ha R Li 8.6 Gnt	21030675	EUDAMED	Class IIa	Active
Ha B P Li 8.12 Gr	21045454	EUDAMED	Class IIa	Active
Ha Ampli-Mini R 3 Ax 312 Bg	21015155	EUDAMEDFDA UDI	Class IIa	Active
Ha Motion C&G M 1ix Prl	21043823	EUDAMED	Class IIa	Active
Ha Moment Mbr3d 220 Mtqs	21007185	EUDAMEDFDA UDI	Class IIa	Active
S_ite Reachcrosixciclisrblk Blk	21035223	EUDAMEDFDA UDI	Class IIa	Active
Ha Koj Rlx 1 Sb	21017557	EUDAMED	Class IIa	Active
Ha Hp Li-Ion 4 G6 Sb	10996278	EUDAMED	Class IIa	Active
Ha Vio E24 Style Blk Slv	21016407	EUDAMED	Class IIa	Active
Ha Mojo Mbb3d M3 Tcblk	21007465	EUDAMED	Class IIa	Active
Kit Bicore C R-Li T D [uk] 1 Gr	21009355	EUDAMEDFDA UDI	Class IIa	Active
Kit Reach R-Li 80 [ca] 1 Gnt	21037033	EUDAMED	Class IIa	Active

WSAUD A/S

About

What WSAUD A/S makes

Frequently asked questions

Information

Catalogue (7919)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities