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
Crissy	13230111	EUDAMED	Class I	Active
Cross 6	13246610	EUDAMED	Class I	Active
Cross 5XL	13126922	EUDAMED	Class I	Active
StarLock	ESSL31717-1IC	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA31315-1	EUDAMEDFDA UDI	Class I	Active
Feed	80403102	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51614-1N	EUDAMEDFDA UDI	Class I	Active
Prio	13425805	EUDAMED	Class I	Active
Rex	81705050	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31111-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41719-1N	EUDAMEDFDA UDI	Class I	Active
Swift Mobil Tilt-2	80229415	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1513-1	EUDAMEDFDA UDI	Class I	Active
Relax	81703050	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21915-1IC	EUDAMEDFDA UDI	Class I	Active
Swift Mobil-2	80229418	EUDAMED	Class I	Active
Standard Air	ESMC1517-1	EUDAMEDFDA UDI	Class I	Active
Alto	80229603	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31519-1IC	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA31721-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246611	EUDAMED	Class I	Active
StarLock	ESSL31715-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13240114	EUDAMED	Class I	Active
Clean	80229318	EUDAMED	Class I	Active
Cross 6	13246003	EUDAMED	Class I	Active
Hi-Loo	80301105	EUDAMEDFDA UDI	Class I	Active
Uni	80503003	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123118	EUDAMED	Class I	Active
Prio	13424117	EUDAMED	Class I	Active
StarLock	ESSL21115-1IC	EUDAMEDFDA UDI	Class I	Active
Hi-Loo Fixed	80301316-2	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC2115-1	EUDAMEDFDA UDI	Class I	Active
Hi-Loo Fixed	80301115-2	EUDAMED	Class I	Active
StarLock	ESSL51212-1	EUDAMEDFDA UDI	Class I	Active
Lille Viking	28619	EUDAMED	Class I	Active
Cross 5XL	13123322	EUDAMED	Class I	Active
Prio	13424713	EUDAMED	Class I	Active
StabilAir	ESSA31115-1	EUDAMEDFDA UDI	Class I	Active
Tasty	80404002	EUDAMED	Class I	Active
Standard Air	ESSC1519-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13240202	EUDAMED	Class I	Active
Standard Air	ESSC2121-2	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1717-1N	EUDAMED	Class I	Active
Swift	81701550	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126412	EUDAMED	Class I	Active
Xact	13250110	EUDAMED	Class I	Active
StarLock	ESSL41313-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31919-1	EUDAMEDFDA UDI	Class I	Active
Swift Mobil 24"-2	80229408	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL30913-1IC	EUDAMEDFDA UDI	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)