Question 1

What types of medical devices does AQ Solutions GmbH manufacture?

Accepted Answer

AQ Solutions GmbH specializes in acetabular orthopaedic reamers and trial components specifically for hip replacement surgery. Their portfolio includes trial cups (such as right and left-handed versions with flanges), trial stems (curved or straight), trial heads with threads, modular extensions (like EF modules and trochanter form broaches), and trial inlays. These devices are designed to assist surgeons during intraoperative fitting and alignment of hip implants.

Question 2

Where is AQ Solutions GmbH based, and what region does it primarily serve?

Accepted Answer

AQ Solutions GmbH is based in Germany. Their devices are registered for commercial distribution within the European market, adhering to EU medical device regulations. The company’s focus aligns with EU regulatory requirements, ensuring compliance for distribution across the region.

Question 3

Which regulatory registries list AQ Solutions GmbH’s devices?

Accepted Answer

AQ Solutions GmbH’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry tracks devices that have undergone the necessary regulatory processes under EU medical device legislation, ensuring transparency and traceability for authorized products.

Question 4

How are AQ Solutions GmbH’s devices classified under EU regulations?

Accepted Answer

AQ Solutions GmbH’s devices fall under Class IIa classification according to EU medical device regulations. This classification applies to devices that pose a moderate risk and require conformity assessment procedures, including clinical evaluations and technical documentation reviews, to ensure safety and performance before authorization.

Device	Model / Reference	Registries	Class	Status
Trial cup M with flange, right	02004176	EUDAMED	Class IIa	Active
Trial cup M standard	02003076	EUDAMED	Class IIa	Active
Form broach trochanter EF module	00200198	EUDAMED	Class IIa	Active
Trial head with thread	00199771	EUDAMED	Class IIa	Active
Trial extensio module	70300009	EUDAMED	Class IIa	Active
Trial cup M with flange, left	02004068	EUDAMED	Class IIa	Active
Trial stem, curved	70300063	EUDAMED	Class IIa	Active
Trial cup S	02005358	EUDAMED	Class IIa	Active
Trial stem, straight	70300059	EUDAMED	Class IIa	Active
Trial EF module	70300172	EUDAMED	Class IIa	Active
Trial inlay S	02363554	EUDAMED	Class IIa	Active
Trial stem, straight	70300017	EUDAMED	Class IIa	Active
Trial cup S	02005344	EUDAMED	Class IIa	Active
Trial cup M standard	02003052	EUDAMED	Class IIa	Active
Trial trochanter module	70300067	EUDAMED	Class IIa	Active
Drill for fixation peg, AO large	02004730	EUDAMED	Class IIa	Active
Trial connector EF module	70300108	EUDAMED	Class IIa	Active
Form broach trochanter EF module	00200199	EUDAMED	Class IIa	Active
Trial inlay S/M	02325060	EUDAMED	Class IIa	Active
Trial cup M standard	02003064	EUDAMED	Class IIa	Active
Threaded fixation pin	03000008	EUDAMED	Class IIa	Active
Trial inlay S/M	02323052	EUDAMED	Class IIa	Active
Intramedullary Drill, AO large	03000039	EUDAMED	Class IIa	Active
Trial double cone 0°	01930816	EUDAMED	Class IIa	Active
Protection cap EF module	70300229	EUDAMED	Class IIa	Active
Trial extensio module	70300010	EUDAMED	Class IIa	Active
Trial inlay S/M	02367068	EUDAMED	Class IIa	Active
Trial cup S	02005346	EUDAMED	Class IIa	Active
Trial inlay S	02282550	EUDAMED	Class IIa	Active
Trial stem, straight	70300123	EUDAMED	Class IIa	Active
Trial cup M standard	02003048	EUDAMED	Class IIa	Active
Form broach trochanter EF module	00200200	EUDAMED	Class IIa	Active
Trial cup M with flange, left	02004072	EUDAMED	Class IIa	Active
Trial cup S	02005368	EUDAMED	Class IIa	Active
Trial connector arthrodesis module	70300109	EUDAMED	Class IIa	Active
Trial double cone 5°	01930868	EUDAMED	Class IIa	Active
Trial stem, straight	70300060	EUDAMED	Class IIa	Active
Trial stem, straight	70300019	EUDAMED	Class IIa	Active
Trial stem, curved	70300022	EUDAMED	Class IIa	Active
Trial connector TF	70300014	EUDAMED	Class IIa	Active
Form broach trochanter EF module distal	00200360	EUDAMED	Class IIa	Active
Trial cup M standard	02003072	EUDAMED	Class IIa	Active
Trial stem, curved	70300021	EUDAMED	Class IIa	Active
Trial inlay S/M	02281044	EUDAMED	Class IIa	Active
Trial extensio module	70300013	EUDAMED	Class IIa	Active
Trial cup M standard	02003068	EUDAMED	Class IIa	Active
Trial stem, curved	70300023	EUDAMED	Class IIa	Active
Trial condylar replacement	70300153	EUDAMED	Class IIa	Active
Trial cup S	02005352	EUDAMED	Class IIa	Active
Trial extensio module for implanted stem	70300107	EUDAMED	Class IIa	Active

AQ Solutions GmbH

What AQ Solutions GmbH makes

Frequently asked questions

Information

Catalogue (74)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities