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
Aktiv	80505005	EUDAMEDFDA UDI	Class I	Active
Swift Mobil 24"-2	80229487	EUDAMED	Class I	Active
Standard Air	ESSCS0911-1	EUDAMEDFDA UDI	Class I	Active
Flex	81707210	EUDAMEDFDA UDI	Class I	Active
Edge	81801060	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL22119-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51212-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL42119-1IZ	EUDAMEDFDA UDI	Class I	Active
Hi-Loo Fixed	80301107	EUDAMED	Class I	Active
Clean	80229270	EUDAMEDFDA UDI	Class I	Active
Clean	80229221	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA41315-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21717-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41313-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21517-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13240215	EUDAMED	Class I	Active
StarLock	ESSL41915-1N	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246202	EUDAMED	Class I	Active
StabilAir	ESSA41511-1	EUDAMEDFDA UDI	Class I	Active
Fresh	81600014	EUDAMEDFDA UDI	Class I	Active
Cross 6	13243105	EUDAMED	Class I	Active
StarLock	ESSL41311-1IC	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA40913-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41311-1	EUDAMEDFDA UDI	Class I	Active
Swift Commode	81702060	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31317-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL22115-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51012-1	EUDAMEDFDA UDI	Class I	Active
Prio	13425213	EUDAMED	Class I	Active
Prio	13425505	EUDAMED	Class I	Active
StarLock	ESSL51822-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51816-1N	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1713-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51822-1IZ	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126416	EUDAMED	Class I	Active
StarLock	ESSL40913-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41513-1	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126914	EUDAMED	Class I	Active
StarLock	ESSL40909-1N	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126319	EUDAMED	Class I	Active
Cross 6	13246608	EUDAMED	Class I	Active
Clean Height Adjustable	80229207	EUDAMED	Class I	Active
Light	80403003	EUDAMEDFDA UDI	Class I	Active
Xact	13250210	EUDAMED	Class I	Active
Cross 6	13246615	EUDAMED	Class I	Active
Beauty	80210070	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51014-1N	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1721-2	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21317-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1111-1	EUDAMEDFDA UDI	Class I	Active

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