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	ESSL51820-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL52022-1IZ	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126322	EUDAMED	Class I	Active
Smart	81951060	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL40911-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51622-1	EUDAMEDFDA UDI	Class I	Active
Cross 5	13123014-R	EUDAMED	Class I	Active
Light	80401007	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41113-1N	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1917-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41521-1N	EUDAMEDFDA UDI	Class I	Active
My-Loo	80301523	EUDAMED	Class I	Active
Prio	13423313	EUDAMED	Class I	Active
Standard Air	ESSC1111-1	EUDAMEDFDA UDI	Class I	Active
Swift Mobil-2	80229420	EUDAMED	Class I	Active
StarLock	ESSL51814-1	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA41919-1	EUDAMED	Class I	Active
StarLock	ESSL21317-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123421	EUDAMED	Class I	Active
StabilAir	ESSA41717-1N	EUDAMED	Class I	Active
StarLock	ESSL30911-1	EUDAMEDFDA UDI	Class I	Active
Clean	80229224	EUDAMEDFDA UDI	Class I	Active
Cross	13120103-R	EUDAMED	Class I	Active
StarLock	ESSL30909-1IC	EUDAMEDFDA UDI	Class I	Active
Cross	13120111-R	EUDAMED	Class I	Active
Cross 6	13240111	EUDAMED	Class I	Active
StarLock	ESSL41513-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31311-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL42115-1	EUDAMEDFDA UDI	Class I	Active
Prio	13423105	EUDAMED	Class I	Active
Hi-Loo Fixed	1318-2	EUDAMED	Class I	Active
StarLock	ESSL51818-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1311-1	EUDAMEDFDA UDI	Class I	Active
Prio	13423909	EUDAMED	Class I	Active
StarLock	ESSL31113-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21113-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21311-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC2121-1	EUDAMEDFDA UDI	Class I	Active
Edge	81801030	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126317	EUDAMED	Class I	Active
My-Loo Fixed	80301514	EUDAMED	Class I	Active
StarLock	ESSL41309-1	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126316	EUDAMED	Class I	Active
Cross 6	13246304	EUDAMED	Class I	Active
StarLock	ESSL31515-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC2117-2	EUDAMEDFDA UDI	Class I	Active
Relax	81708020	EUDAMEDFDA UDI	Class I	Active
Swift	81701410-VG	EUDAMED	Class I	Active
StarLock	ESSL51010-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51820-1	EUDAMEDFDA UDI	Class I	Active

ETAC SUPPLY CENTER AB

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