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	ESSL31721-1IC	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS2117-1	EUDAMEDFDA UDI	Class I	Active
Rex	81705010	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1517-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1917-2	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL42121-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL42117-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41521-1	EUDAMEDFDA UDI	Class I	Active
Cross	13120102-R	EUDAMED	Class I	Active
StarLock	ESSL31317-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41519-1N	EUDAMEDFDA UDI	Class I	Active
Cross 5	13123008-R	EUDAMED	Class I	Active
Clean	80229326	EUDAMED	Class I	Active
Cross 5XL	13126115	EUDAMED	Class I	Active
StarLock	ESSL51614-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1915-2	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1721-1	EUDAMEDFDA UDI	Class I	Active
Swift Freestanding	81702025	EUDAMED	Class I	Active
StarLock	ESSL51618-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL32119-1	EUDAMEDFDA UDI	Class I	Active
Smart	81951010	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL52216-1N	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA31713-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31513-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41513-1N	EUDAMEDFDA UDI	Class I	Active
Cross	13120114-R	EUDAMED	Class I	Active
StabilAir	ESSA31311-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41921-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41517-1	EUDAMEDFDA UDI	Class I	Active
Prio	13423705	EUDAMED	Class I	Active
Prio	13424417	EUDAMED	Class I	Active
StarLock	ESSL31511-1IC	EUDAMEDFDA UDI	Class I	Active
Alto	80229600	EUDAMED	Class I	Active
Butler	80602004	EUDAMEDFDA UDI	Class I	Active
Flex	81706110	EUDAMED	Class I	Active
StarLock	ESSL31315-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1717-1N	EUDAMED	Class I	Active
Swift	81701460	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL52216-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21917-1	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA30911-1	EUDAMEDFDA UDI	Class I	Active
Swift Freestanding	81702020	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31311-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126318	EUDAMED	Class I	Active
Hi-Loo Fixed	80301318-2	EUDAMED	Class I	Active
StarLock	ESSL40911-1IC	EUDAMEDFDA UDI	Class I	Active
Crissy	13230105	EUDAMED	Class I	Active
Swift Mobil 24"-2	80229464	EUDAMED	Class I	Active
Prio	13423809	EUDAMED	Class I	Active
Cross 5XL	13126418	EUDAMED	Class I	Active

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