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
StabilAir	ESSA41713-1	EUDAMEDFDA UDI	Class I	Active
Aktiv	80505007	EUDAMEDFDA UDI	Class I	Active
Swift	81701620	EUDAMEDFDA UDI	Class I	Active
Light	80402002	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1115-1	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123419	EUDAMED	Class I	Active
My-Loo	80301520	EUDAMED	Class I	Active
Aktiv	80505004	EUDAMEDFDA UDI	Class I	Active
Swift Mobil Tilt-2	80229412	EUDAMEDFDA UDI	Class I	Active
Tasty	80404004	EUDAMED	Class I	Active
StarLock	ESSL20911-1	EUDAMEDFDA UDI	Class I	Active
My-Loo Fixed	80301511	EUDAMED	Class I	Active
Fresh	81600021	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123416	EUDAMED	Class I	Active
StarLock	ESSL31919-1IC	EUDAMEDFDA UDI	Class I	Active
Rex	81705040	EUDAMEDFDA UDI	Class I	Active
Clean	80229213	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL52020-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1915-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1511-1	EUDAMEDFDA UDI	Class I	Active
Swift Mobil 24"-2	80229407	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1717-1	EUDAMEDFDA UDI	Class I	Active
Flex	81706410	EUDAMED	Class I	Active
Cross 6	13240216	EUDAMED	Class I	Active
StabilAir	ESSA30913-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41519-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31313-1	EUDAMEDFDA UDI	Class I	Active
Alto	80229610	EUDAMED	Class I	Active
StarLock	ESSL51410-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31519-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41719-1IZ	EUDAMEDFDA UDI	Class I	Active
Clean 24"	80229216	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51010-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123422	EUDAMED	Class I	Active
Swift Mobil Tilt-2	80229410	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41315-1N	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1917-1	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123312	EUDAMED	Class I	Active
Cloo	80301204	EUDAMED	Class I	Active
StarLock	ESSL31713-1IC	EUDAMEDFDA UDI	Class I	Active
Xact	13250111	EUDAMED	Class I	Active
StarLock	ESSL41517-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL32121-1	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123112	EUDAMED	Class I	Active
StarLock	ESSL41111-1N	EUDAMEDFDA UDI	Class I	Active
Swift Mobil-2	80229498	EUDAMED	Class I	Active
StarLock	ESSL32117-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51012-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123316	EUDAMED	Class I	Active
Tasty	80404005	EUDAMEDFDA UDI	Class I	Active

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