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	ESSL21519-1	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA41717-1	EUDAMED	Class I	Active
StarLock	ESSL51612-1IC	EUDAMEDFDA UDI	Class I	Active
Xact	13250101	EUDAMED	Class I	Active
StarLock	ESSL51014-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31921-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 6	13240208	EUDAMED	Class I	Active
StarLock	ESSL41713-1N	EUDAMEDFDA UDI	Class I	Active
Alto	80229608	EUDAMED	Class I	Active
Relieve	80402101	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL42117-1IZ	EUDAMEDFDA UDI	Class I	Active
Transit	13145309	EUDAMED	Class I	Active
StabilAir	ESSA41313-1	EUDAMED	Class I	Active
Cross 6	13246114	EUDAMED	Class I	Active
StarLock	ESSL21517-1IC	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1111-1	EUDAMEDFDA UDI	Class I	Active
Swift Mobil Tilt-2	80229480	EUDAMEDFDA UDI	Class I	Active
Swift Mobil-2	80229486	EUDAMEDFDA UDI	Class I	Active
Cross	13120108-R	EUDAMED	Class I	Active
Standard Air	ESSC1717-2	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41721-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51614-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31915-1IC	EUDAMEDFDA UDI	Class I	Active
Swift Mobil-2	80229483	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1309-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21917-1IC	EUDAMEDFDA UDI	Class I	Active
Prio	13426605	EUDAMED	Class I	Active
Feed	80403101	EUDAMEDFDA UDI	Class I	Active
Edge	81801010-VG	EUDAMEDFDA UDI	Class I	Active
Clean	80229223	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51612-1	EUDAMEDFDA UDI	Class I	Active
Relax	81703020	EUDAMEDFDA UDI	Class I	Active
Prio	13424205	EUDAMED	Class I	Active
Tasty	80404042	EUDAMEDFDA UDI	Class I	Active
My-Loo Fixed	80301512	EUDAMED	Class I	Active
StarLock	ESSL41917-1N	EUDAMEDFDA UDI	Class I	Active
Feed	80403302	EUDAMEDFDA UDI	Class I	Active
Clean	80229296	EUDAMED	Class I	Active
Aktiv	80505006	EUDAMEDFDA UDI	Class I	Active
Smart	81951080	EUDAMED	Class I	Active
Cross 5XL	13123415	EUDAMED	Class I	Active
StarLock	ESSL31515-1IC	EUDAMEDFDA UDI	Class I	Active
Prio	13423309	EUDAMED	Class I	Active
Cross 6	13246110	EUDAMED	Class I	Active
StarLock	ESSL31917-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51210-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL30913-1	EUDAMEDFDA UDI	Class I	Active
Clean	80229271	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA41521-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21511-1	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)