Question 1

What types of medical devices does ETAC Supply Center AB manufacture?

Accepted Answer

ETAC Supply Center AB specializes in hydrotherapy baths and tanks, which are primarily used for physical therapy and rehabilitation. These devices deliver controlled water-based treatments to aid patient recovery. The company’s products are tailored for clinical settings where hydrotherapy is a key component of care.

Question 2

Where is ETAC Supply Center AB based, and how does that affect its regulatory standing?

Accepted Answer

ETAC Supply Center AB is based in Sweden, which places its devices under EU medical device regulations. Since these products fall under Class I classification, they are subject to EU requirements for conformity assessment and registration. The company’s devices are listed in the EUDAMED database, demonstrating compliance with EU regulatory processes.

Question 3

Which regulatory registries list ETAC Supply Center AB’s devices, and why?

Accepted Answer

ETAC Supply Center AB’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registry ensures transparency and traceability of Class I devices under EU regulations, allowing healthcare providers, regulators, and authorities to verify compliance and device details.

Question 4

How are ETAC Supply Center AB’s hydrotherapy devices classified, and what does that mean for their use?

Accepted Answer

ETAC Supply Center AB’s hydrotherapy baths and tanks are classified as EU Class I medical devices. This classification means they pose minimal risk and typically require basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU safety and performance standards before being placed on the market.

Device	Model / Reference	Registries	Class	Status
StarLock	ESSL51822-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246102	EUDAMED	Class I	Active
Relax	81703010	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246309	EUDAMED	Class I	Active
StarLock	ESSL52222-1N	EUDAMEDFDA UDI	Class I	Active
Xact	13250106	EUDAMED	Class I	Active
Standard Air	ESMC2119-1	EUDAMEDFDA UDI	Class I	Active
Relax	81708010	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41109-1	EUDAMEDFDA UDI	Class I	Active
Clean 24"	80229324	EUDAMED	Class I	Active
StarLock	ESSL51216-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21313-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246605	EUDAMED	Class I	Active
Cross 5XL	13126113	EUDAMED	Class I	Active
Socky	80601003-2	EUDAMED	Class I	Active
Prio	13425117	EUDAMED	Class I	Active
StabilAir	ESSA31111-1	EUDAMEDFDA UDI	Class I	Active
Cross	13120115-R	EUDAMED	Class I	Active
StarLock	ESSL22119-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126916	EUDAMED	Class I	Active
Cross 6	13246308	EUDAMED	Class I	Active
Prio	13426017	EUDAMED	Class I	Active
Prio	13424705	EUDAMED	Class I	Active
Flex	81707420	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1919-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51418-1N	EUDAMEDFDA UDI	Class I	Active
Crissy	13230103	EUDAMED	Class I	Active
Standard Air	ESSCS1921-1	EUDAMEDFDA UDI	Class I	Active
Feed	80403103	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41317-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41517-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31111-1	EUDAMEDFDA UDI	Class I	Active
Rex	81705030	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41313-1N	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1315-2	EUDAMEDFDA UDI	Class I	Active
Relax	81708050	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC2121-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41717-1N	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1519-1	EUDAMEDFDA UDI	Class I	Active
Prio	13424413	EUDAMED	Class I	Active
StarLock	ESSL51814-1N	EUDAMEDFDA UDI	Class I	Active
Light	80402004	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21513-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 6	13240210	EUDAMED	Class I	Active
Prio	13426117	EUDAMED	Class I	Active
Prio	13421413	EUDAMED	Class I	Active
StarLock	ESSL51014-1IC	EUDAMEDFDA UDI	Class I	Active
Swift	81701480	EUDAMED	Class I	Active
StarLock	ESSL52222-1	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA41519-1	EUDAMEDFDA UDI	Class I	Active

ETAC SUPPLY CENTER AB

What ETAC SUPPLY CENTER AB makes

Frequently asked questions

Information

Catalogue (900)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)