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	ESSL31511-1	EUDAMEDFDA UDI	Class I	Active
Cross 5	13123016-R	EUDAMED	Class I	Active
Cross 5XL	13126313	EUDAMED	Class I	Active
StarLock	ESSL31315-1IC	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA41721-1	EUDAMED	Class I	Active
Prio	13420417	EUDAMED	Class I	Active
Clean	80229274	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41515-1IZ	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246209	EUDAMED	Class I	Active
StarLock	ESSL41309-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126121	EUDAMED	Class I	Active
Cross 5XL	13126413	EUDAMED	Class I	Active
Swift	81701730	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21111-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51214-1	EUDAMEDFDA UDI	Class I	Active
Xact	13250209	EUDAMED	Class I	Active
Easy	81901020	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1721-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51620-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL52018-1N	EUDAMEDFDA UDI	Class I	Active
Alto	80229612	EUDAMED	Class I	Active
Cross 5XL	13123311	EUDAMED	Class I	Active
Swift	81701630	EUDAMEDFDA UDI	Class I	Active
Prio	13424113	EUDAMED	Class I	Active
Prio	13426713	EUDAMED	Class I	Active
Cross 6	13246101	EUDAMED	Class I	Active
Clean 24"	80229327	EUDAMED	Class I	Active
Cross 6	13246011	EUDAMED	Class I	Active
StarLock	ESSL51214-1N	EUDAMEDFDA UDI	Class I	Active
Prio	13424405	EUDAMED	Class I	Active
Standard Air	ESSC1715-2	EUDAMEDFDA UDI	Class I	Active
Cross 5	13123011-R	EUDAMED	Class I	Active
Standard Air	ESSC1317-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL52216-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL52218-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31109-1IC	EUDAMEDFDA UDI	Class I	Active
Hi-Loo Fixed	1317-2	EUDAMED	Class I	Active
Prio	13426305	EUDAMED	Class I	Active
Cross 6	13246001	EUDAMED	Class I	Active
StabilAir	ESSA31917-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1917-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246015	EUDAMED	Class I	Active
Fix	80501004	EUDAMEDFDA UDI	Class I	Active
Flex	81707120	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1517-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1719-2	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246314	EUDAMED	Class I	Active
StarLock	ESSL51214-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41919-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41111-1	EUDAMEDFDA UDI	Class I	Active

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