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	ESSL51414-1N	EUDAMEDFDA UDI	Class I	Active
Clean	80229284	EUDAMED	Class I	Active
StarLock	ESSL51616-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41515-1N	EUDAMEDFDA UDI	Class I	Active
Aktiv	80505008	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL52020-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51010-1N	EUDAMEDFDA UDI	Class I	Active
Clean	80229218	EUDAMED	Class I	Active
Standard Air	ESMC1115-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC2117-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1313-2	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA32121-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1717-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL52218-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13240110	EUDAMED	Class I	Active
Swift	81701530	EUDAMEDFDA UDI	Class I	Active
OptimaL	80303006	EUDAMED	Class I	Active
Beauty	80210082	EUDAMEDFDA UDI	Class I	Active
Prio	13425609	EUDAMED	Class I	Active
StarLock	ESSL21309-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1713-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41309-1N	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1717-1N	EUDAMEDFDA UDI	Class I	Active
Prio	13426105	EUDAMED	Class I	Active
StarLock	ESSL21315-1IC	EUDAMEDFDA UDI	Class I	Active
Kaskad	80302012	EUDAMED	Class I	Active
StarLock	ESSL30909-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL22121-1	EUDAMEDFDA UDI	Class I	Active
Relieve	80501101	EUDAMEDFDA UDI	Class I	Active
Swift	81701450	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51618-1N	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123111	EUDAMED	Class I	Active
Cross 6	13246311	EUDAMED	Class I	Active
Cross 6	13246204	EUDAMED	Class I	Active
StarLock	ESSL22115-1IC	EUDAMEDFDA UDI	Class I	Active
Prio	13425909	EUDAMED	Class I	Active
Alto	80229611	EUDAMED	Class I	Active
Contour	80701001	EUDAMED	Class I	Active
Hi-Loo	80301101	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA31511-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21111-1	EUDAMEDFDA UDI	Class I	Active
Xact	13250112	EUDAMED	Class I	Active
StarLock	ESSL40913-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1921-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1313-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL42115-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41113-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41511-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1109-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51612-1N	EUDAMEDFDA UDI	Class I	Active

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