Question 1

What types of medical devices does Soluscope SAS manufacture?

Accepted Answer

Soluscope SAS produces a range of dental medical devices, including handpieces like the Soluscope™ P and Soluscope™ GTA, ultrasonic scalers such as the Soluscope™ Serie TEE, and air-water syringes like the SOLUSCOPE A. Their portfolio also includes disinfectant systems (e.g., Soluscope™ PAA), enzymatic cleaners (e.g., SOLUSCOPE ECL-ENZYMATIC CLEANER 2X5L), and other dental hygiene tools like the SOLUSCOPE C+ and SOLUSCOPE CLN. These devices are designed for use in dental procedures and equipment maintenance.

Question 2

Where is Soluscope SAS based, and what regulatory framework does it follow?

Accepted Answer

Soluscope SAS is based in France. The company’s devices are developed and distributed in accordance with EU medical device regulations, ensuring compliance with the requirements for safety, performance, and market placement within the European Union. This includes adherence to classification rules under EU directives, which determine how devices are authorised for use.

Question 3

Which regulatory registries list Soluscope SAS’s devices?

Accepted Answer

Soluscope SAS’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices authorised for use within the EU market, including their classification and manufacturer details.

Question 4

How are Soluscope SAS’s devices classified under EU regulations?

Accepted Answer

Soluscope SAS’s devices are classified under the EU Medical Device Regulations (MDR) as either Class I or Class IIb. Classification determines the level of scrutiny and regulatory requirements a device must meet before it can be placed on the market. For example, handpieces like the Soluscope™ P may fall under Class I due to their lower risk profile, while more complex devices like certain ultrasonic scalers or disinfectant systems could be classified as Class IIb due to higher associated risks.

Question 5

Are Soluscope SAS’s devices authorised for use outside the European Union?

Accepted Answer

The provided information only confirms that Soluscope SAS’s devices are registered in the eudamed database, which is specific to the EU market. Whether these devices are authorised or cleared for use in other regions (e.g., the US under FDA regulations, or other global markets) would depend on additional compliance processes specific to those jurisdictions, which are not detailed here.

Device	Model / Reference	Registries	Class	Status
Soluscope™ Serie TEE	SL-TEE-ECL	EUDAMED	Class IIb	Active
Soluscope™ P	1339525GZ	EUDAMED	Class IIb	Active
Soluscope™ PAA	2206736E7	EUDAMED	Class IIb	Active
Soluscope™ GTA	2484447FG	EUDAMED	Class IIb	Active
Soluscope C+	3160369EO	EUDAMED	Class I	Active
Soluscope Cln	2205737E7	EUDAMED	Class I	Active
Soluscope™ PAA	22067368T	EUDAMED	Class IIb	Active
Soluscope™ GTA	24844478R	EUDAMED	Class IIb	Active
Soluscope™ PA	2295796GZ	EUDAMED	Class IIb	Active
Soluscope™ GTA	248444742	EUDAMED	Class IIb	Active
Soluscope Ecl-Enzymatic Cleaner 2x5l	31144859B	EUDAMED	Class I	Active
Soluscope™ Serie TEE	SL-TEE	EUDAMED	Class IIb	Active
Soluscope A	13382828X	EUDAMED	Class IIb	Active
Soluscope™ D	25336828P	EUDAMED	Class IIb	Active
Soluscope™ Serie 1	SL-V1-GTA	EUDAMED	Class IIb	Active
Soluscope P	13395258V	EUDAMED	Class IIb	Active
Soluscope™ PAA	2206736GZ	EUDAMED	Class IIb	Active
Soluscope Cln	22057379C	EUDAMED	Class I	Active
Soluscope™ PA	22957968S	EUDAMED	Class IIb	Active
Soluscope™ P	1241525	EUDAMED	Class IIb	Active
Soluscope™ PAA	22067364Z	EUDAMED	Class IIb	Active
Module Endoscopique Easytouch	406700MET0065	EUDAMED	Class I	Active
Soluscope™ PA	2295796FG	EUDAMED	Class IIb	Active
Soluscope Ez	2483444FG	EUDAMED	Class I	Active
Soluscope C+	3160369S3	EUDAMED	Class I	Active
Soluscope™ Serie TEE	SL-TEE-AT-ECL	EUDAMED	Class IIb	Active
Soluscope™ PAA	2148736	EUDAMED	Class IIb	Active
Soluscope™ Serie 1	SL-V1-PA	EUDAMED	Class IIb	Active
Soluscope™ PA	22957968D	EUDAMED	Class IIb	Active
Dsc 8000	SC8-2D-C	EUDAMED	Class I	Active
Soluscope P	13395259P	EUDAMED	Class IIb	Active
Soluscope™ Serie 1	SL-V1-AL-GTA	EUDAMED	Class IIb	Active
Soluscope D	25336824R	EUDAMED	Class IIb	Active
Soluscope™ D	2533682LG	EUDAMED	Class IIb	Active
Soluscope Ecl-Enzym. Clean. 2x5l + Rfid	3114542BM	EUDAMED	Class I	Active
Soluscope™ CLN	22057374Z	EUDAMED	Class I	Active
Soluscope P	1339525GW	EUDAMED	Class IIb	Active
Soluscope A	13382828Y	EUDAMED	Class IIb	Active
Soluscope P	13395254R	EUDAMED	Class IIb	Active
Soluscope Cln	2147737	EUDAMED	Class I	Active
Dsc 8000	SC8-1D-C	EUDAMED	Class I	Active
Soluscope Ecl-Enzym. Clean. 2x5l + Rfid	3114542BN	EUDAMED	Class I	Active
Soluscope™ GTA	24844478G	EUDAMED	Class IIb	Active
Soluscope™ Serie 4	SL-V4-RO-PA	EUDAMED	Class IIb	Active
Soluscope Ez 4x5l	2483444GZ	EUDAMED	Class I	Active
Soluscope™ Serie 1	SL-V1-AL-PA	EUDAMED	Class IIb	Active
Module Endoscopique Easytouch	406700MET0067	EUDAMED	Class I	Active
Soluscope™ A	1338282GZ	EUDAMED	Class IIb	Active
Soluscope™ PAA	22067368U	EUDAMED	Class IIb	Active
Module Endoscopique Easytouch	406700MET0069	EUDAMED	Class I	Active

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