Question 1

What types of medical devices does Akzenta International SA manufacture?

Accepted Answer

Akzenta International SA specializes in dental medical devices. Their portfolio includes product lines like PURE|ONE, MEDIBASE, PURE PLANET, and STARLINE, which consist of dental materials and equipment designed for clinical use. These devices are tailored for dental procedures and patient care.

Question 2

Where is Akzenta International SA based?

Accepted Answer

Akzenta International SA is headquartered in Switzerland. The company’s location in Switzerland aligns with regulatory standards in the European Union, where its devices are also tracked.

Question 3

Which regulatory registries list Akzenta International SA’s devices?

Accepted Answer

Akzenta International SA’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This listing ensures transparency and compliance with EU regulatory requirements.

Question 4

How are Akzenta International SA’s devices classified under EU regulations?

Accepted Answer

Akzenta International SA’s devices fall under Class I classification in the EU regulatory framework. Class I devices are generally considered low-risk, often involving simple tools or materials like dental consumables, and require specific conformity assessment procedures before market placement.

Device	Model / Reference	Registries	Class	Status
Pure\|one	GLOBY53-AKZ-LA-LL1	EUDAMED	Class I	Active
Medibase	3136862	EUDAMED	Class I	Active
Pure Planet	PATHY15-AKZ-WH-C35	EUDAMED	Class I	Active
Medibase	3136866	EUDAMED	Class I	Active
Starline	VE33542-V	EUDAMED	Class I	Active
Pure\|one	GLOBY53-AKZ-LA-XS1	EUDAMED	Class I	Active
Pure\|one	GLOBY53-AKZ-LA-S01	EUDAMED	Class I	Active
Starline	VE33542	EUDAMED	Class I	Active
Starline	VE33548	EUDAMED	Class I	Active
Starline	VE33546-V	EUDAMED	Class I	Active
Starline	VE33544-V	EUDAMED	Class I	Active
Starline	VE33544	EUDAMED	Class I	Active
Starline	VE33548-V	EUDAMED	Class I	Active
Medibase	3136863	EUDAMED	Class I	Active
Prime\|one	GLOBN53-AKZ-DW-S01	EUDAMED	Class I	Active
Art\|one	GLOBN56-AKZ-PI-S01	EUDAMED	Class I	Active
Smart\|one	GLOFL29-AKZ-WH-S01	EUDAMED	Class I	Active
Centra	1090913	EUDAMED	Class I	Active
Starline	VE33544-B	EUDAMED	Class I	Active
Like	PD000004	EUDAMED	Class I	Active
Pure	231784	EUDAMED	Class I	Active
Orbis	312423	EUDAMED	Class I	Active
Medibase	3136865	EUDAMED	Class I	Active
Smart\|one	GLOFL29-AKZ-WH-XS1	EUDAMED	Class I	Active
Pure\|one	GLOBY53-AKZ-LA-M01	EUDAMED	Class I	Active
Pure	231785	EUDAMED	Class I	Active
Centra	1090862	EUDAMED	Class I	Active
Smart\|one	GLOFL29-AKZ-WH-LL1	EUDAMED	Class I	Active
Centra	1090857	EUDAMED	Class I	Active
Art\|one	GLOBN56-AKZ-PI-M01	EUDAMED	Class I	Active
Prime\|one	GLOCL60-AKZ-WH-LL1	EUDAMED	Class I	Active
Starline	VE33548-B	EUDAMED	Class I	Active
Smart\|one	GLOBN51-AKZ-WH-XS1	EUDAMED	Class I	Active
Dental Xl	DXL221	EUDAMED	Class I	Active
Prime\|one	GLOBY53-AKZ-TL-M01	EUDAMED	Class I	Active
Like	PD000003	EUDAMED	Class I	Active
Art\|one	GLODL29-AKZ-WH-XS1	EUDAMED	Class I	Active
Starline	VE33542-B	EUDAMED	Class I	Active
Art\|one	GLOBN56-AKZ-PH-S01	EUDAMED	Class I	Active
Orbis	312417	EUDAMED	Class I	Active
Prime\|one	GLOBN53-AKZ-DW-M01	EUDAMED	Class I	Active
Art\|one	GLOEL53-AKZ-WH-XS1	EUDAMED	Class I	Active
Orbis	312422	EUDAMED	Class I	Active
Centra	1091010	EUDAMED	Class I	Active
Orbis	312425	EUDAMED	Class I	Active
Prime\|one	GLOCL60-AKZ-WH-XS1	EUDAMED	Class I	Active
Centra	1090914	EUDAMED	Class I	Active
Orbis	312421	EUDAMED	Class I	Active
Orbis	312426	EUDAMED	Class I	Active
Prime\|one	GLOCL60-AKZ-WH-M01	EUDAMED	Class I	Active

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