Question 1

What types of medical devices does ACTO GmbH manufacture?

Accepted Answer

ACTO GmbH specializes in dental and oral hygiene solutions. Their portfolio includes antiseptic mouthwashes like Actosept AF and Actosept AF Citrus, disinfectant gels such as Aclind w Gel, dental instrument cleaning solutions like Actodent Bohrerbad, antiseptic sprays including Actoanid Spray, and specialized rinses for oral care procedures such as Actosed OPA and Actosed PA Solution. These products are designed for use in dental practices and oral healthcare settings.

Question 2

Where is ACTO GmbH based, and where can I find information about its devices?

Accepted Answer

ACTO GmbH is headquartered in Wietzen-Holte, Germany, with additional operational locations in Braunschweig, Bavaria, and Baden-Württemberg. Their devices are listed in the EU’s official medical device registry, eudamed, where regulatory details such as classification and device identification can be verified. This database is the primary source for tracking authorized medical devices within the European Union.

Question 3

How are ACTO GmbH’s devices classified under EU regulations?

Accepted Answer

ACTO GmbH’s devices are classified under the EU Medical Device Regulations (MDR) based on their intended use and associated risks. Their products fall into Class I (low-risk, non-invasive items like some oral rinses), Class IIa (moderate-risk devices such as certain antiseptic solutions), Class IIb (higher-risk items like specialized dental cleaning agents), and Class III (high-risk devices, if applicable). Classification determines regulatory requirements, including clinical evaluation and conformity assessment procedures.

Question 4

Are ACTO GmbH’s devices listed in any other regulatory registries besides eudamed?

Accepted Answer

Based on the available information, ACTO GmbH’s devices are registered in the eudamed database, which is the EU’s central registry for medical devices. While some manufacturers may also appear in national registries or other databases depending on market access, eudamed is the primary EU-wide source for tracking these products. For comprehensive global visibility, additional registries may apply outside the EU, but those details are not specified here.

Device	Model / Reference	Registries	Class	Status
Actosed OPA 2 L	01.2323.2	EUDAMED	Class IIb	Active
Actolind w Solution 1 L	06.6703.1	EUDAMED	Class III	Active
Actosed Enzym 90 ml	01.7603.90	EUDAMED	Class IIb	Active
Actosed PA Solution 2 L	01.83005.2	EUDAMED	Class IIb	Active
PREVENTIA Surgical Irrigation 350 ml	999 560	EUDAMED	Class III	Active
Actodent Bohrerbad 1 L	01.0501.1	EUDAMED	Class IIb	Active
Actosed PA Powder 810 g	01.9605.810	EUDAMED	Class IIb	Active
Actolind w Gel 10x5 ml	06.6803.05M	EUDAMED	Class III	Active
Acto Oxy Foam 1 L	05.5710.1	EUDAMED	Class IIa	Active
Aclind w Solution 100 ml	06.3848.100	EUDAMED	Class III	Active
Actosept AF 5 L	05.2301.5	EUDAMED	Class IIa	Active
Aclind w Solution 350 ml	06.3848.350	EUDAMED	Class III	Active
Actoanid Spray 750 ml	05.1230.750	EUDAMED	Class IIa	Active
Actosed OPA 1 L	01.2323.1	EUDAMED	Class IIb	Active
Actosept AF Citrus 500 ml	05.2401.500	EUDAMED	Class IIa	Active
Actodent Bohrerbad 2 L	01.0501.2	EUDAMED	Class IIb	Active
Aclind w Solution 1 L	06.3848.1	EUDAMED	Class III	Active
Actosed PA Solution 90 ml	01.83005.90	EUDAMED	Class IIb	Active
Aclind w Solution 5x10 ml	06.3848.10M	EUDAMED	Class III	Active
Actosal Fläche AF New 5 L	05.2222.5	EUDAMED	Class IIa	Active
Aclind w Gel 30 ml	06.3858.30	EUDAMED	Class III	Active
Actosed Endo 90 ml	1.0101.90	EUDAMED	Class IIb	Active
Aclind w Solution 250 ml	06.3848.250	EUDAMED	Class III	Active
Aclind w Gel 10*5 ml	06.3858.05M10	EUDAMED	Class III	Active
Actosept AF 750 ml	05.2301.750	EUDAMED	Class IIa	Active
Actosed OPA 250 ml	01.2323.250	EUDAMED	Class IIb	Active
Actosed HP Ready 5 L	01.7303.5	EUDAMED	Class IIb	Active
Actosept AF 500 ml	05.2301.500	EUDAMED	Class IIa	Active
Actodent Bohrerbad 5 L	01.0501.5	EUDAMED	Class IIb	Active
Cosmos Wound Spray 50 ml	531 030	EUDAMED	Class III	Active
Actodiacit PA 5 L	01.8305.5	EUDAMED	Class IIa	Active
Actodiacit PA 2 L	01.8305.2	EUDAMED	Class IIa	Active
Actosed Plus 5 L	01.4502.5	EUDAMED	Class IIb	Active
Actosept AF Plus 500 ml	05.4849.500	EUDAMED	Class IIa	Active
Actosed Forte Ready 1 L	01.0303.1	EUDAMED	Class IIb	Active
Actosept AF 1 L	05.2301.1	EUDAMED	Class IIa	Active
PREVENTIA Surgical Irrigation 1 L	999 550	EUDAMED	Class III	Active
Actoanid Foam 1 L	05.1220.1	EUDAMED	Class IIa	Active
Acto Oxy Foam 500 ml	05.5710.500	EUDAMED	Class IIa	Active
Actosed Endo Terra 2 L	01.4702.2	EUDAMED	Class IIb	Active
Actosept AF Citrus 5 L	05.2401.5	EUDAMED	Class IIa	Active
Actolind w Solution 5x10 ml	06.6703.10M	EUDAMED	Class III	Active
Sutrisept w Solution 250 ml	06.1568.250	EUDAMED	Class III	Active
Sutrisept w Gel 100 ml	06.3838.100	EUDAMED	Class III	Active
Actosed Endo Terra 90 ml	01.4702.90	EUDAMED	Class IIb	Active
Actosept AF Tücher 100 wipes	05.3101.100	EUDAMED	Class IIa	Active
Actolind w Gel 50 ml	06.6803.50	EUDAMED	Class III	Active
Actosed PA Powder 2 kg	01.9605.2	EUDAMED	Class IIb	Active
Actosed Forte Ready 100 ml	01.0303.100	EUDAMED	Class IIb	Active
Aclind w Gel 250 ml	06.3858.250	EUDAMED	Class III	Active

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