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
Easy	81901080	EUDAMED	Class I	Active
Beauty	80210068	EUDAMEDFDA UDI	Class I	Active
Transit	13140305	EUDAMED	Class I	Active
Cross 5XL	13126414	EUDAMED	Class I	Active
Swift Mobil Tilt-2	80229481	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA30909-1	EUDAMEDFDA UDI	Class I	Active
Prio	13423405	EUDAMED	Class I	Active
Standard Air	ESSCS1717-2	EUDAMEDFDA UDI	Class I	Active
Beauty	80210072	EUDAMEDFDA UDI	Class I	Active
Prio	13426313	EUDAMED	Class I	Active
StarLock	ESSL42117-1N	EUDAMEDFDA UDI	Class I	Active
Prio	13426005	EUDAMED	Class I	Active
Socky	80601001-2	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41515-1	EUDAMEDFDA UDI	Class I	Active
Transit	13145317	EUDAMED	Class I	Active
StabilAir	ESSA40911-1	EUDAMED	Class I	Active
Prio	13425413	EUDAMED	Class I	Active
Feed	80403301	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31915-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41717-1IZ	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126320	EUDAMED	Class I	Active
Lille Viking	28618	EUDAMED	Class I	Active
Prio	13426705	EUDAMED	Class I	Active
Cross 5XL	13123414	EUDAMED	Class I	Active
My-Loo Fixed	80301516	EUDAMED	Class I	Active
Clean	80229269	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL52222-1IZ	EUDAMEDFDA UDI	Class I	Active
Cross 5	13123006-R	EUDAMED	Class I	Active
StarLock	ESSL51816-1	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123320	EUDAMED	Class I	Active
StarLock	ESSL21713-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21515-1	EUDAMEDFDA UDI	Class I	Active
Light	80403202	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA32115-1	EUDAMEDFDA UDI	Class I	Active
Xact	13250104	EUDAMED	Class I	Active
StarLock	ESSL41315-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51410-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL42121-1	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA31313-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246109	EUDAMED	Class I	Active
Easy	81901050	EUDAMEDFDA UDI	Class I	Active
Clean 24"	80229322	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21921-1	EUDAMEDFDA UDI	Class I	Active
Smart	81951020	EUDAMEDFDA UDI	Class I	Active
Swift Mobil-2	80229492	EUDAMED	Class I	Active
Supporter	3112-2	EUDAMED	Class I	Active
Standard Air	ESSC1113-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1719-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51412-1N	EUDAMEDFDA UDI	Class I	Active
Prio	13426709	EUDAMED	Class I	Active

ETAC SUPPLY CENTER AB

What ETAC SUPPLY CENTER AB makes

Frequently asked questions

Information

Catalogue (900)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)