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	ESSL40909-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL40913-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41715-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL20909-1IC	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1719-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL40911-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51210-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1719-1	EUDAMEDFDA UDI	Class I	Active
Aktiv	80505009	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41115-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51818-1IZ	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1719-2	EUDAMEDFDA UDI	Class I	Active
Prio	13424013	EUDAMED	Class I	Active
Crissy	13232103	EUDAMED	Class I	Active
Cross 5	13123004-R	EUDAMED	Class I	Active
Swift Mobil-2	80229463	EUDAMED	Class I	Active
Butler	80602001	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41521-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL42121-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31721-1	EUDAMEDFDA UDI	Class I	Active
Hi-Loo Fixed	80301317-2	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246207	EUDAMED	Class I	Active
Cross 6	13246212	EUDAMED	Class I	Active
Standard Air	ESSC1311-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51618-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51616-1N	EUDAMEDFDA UDI	Class I	Active
Relax	81703030	EUDAMEDFDA UDI	Class I	Active
Alto	80229601	EUDAMED	Class I	Active
Beauty	80210080	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31113-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21311-1IC	EUDAMEDFDA UDI	Class I	Active
Swift	81701420	EUDAMEDFDA UDI	Class I	Active
Clean	80229273	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246205	EUDAMED	Class I	Active
StarLock	ESSL22117-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1515-2	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126913	EUDAMED	Class I	Active
Cross 5XL	13126117	EUDAMED	Class I	Active
Socky	80601002-2	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA31317-1	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA31513-1	EUDAMEDFDA UDI	Class I	Active
Transit	13140311	EUDAMED	Class I	Active
My-Loo Fixed	80301515	EUDAMED	Class I	Active
Clean	80229214	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1717-1IZ	EUDAMED	Class I	Active
StarLock	ESSL51416-1N	EUDAMEDFDA UDI	Class I	Active
Prio	13423917	EUDAMED	Class I	Active
StarLock	ESSL21715-1	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA31519-1	EUDAMEDFDA UDI	Class I	Active
Flex	81706210	EUDAMED	Class I	Active

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