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
Edge	81801010	EUDAMEDFDA UDI	Class I	Active
Fresh	81600014-VG	EUDAMED	Class I	Active
StarLock	ESSL31115-1	EUDAMEDFDA UDI	Class I	Active
Swift	81701510	EUDAMEDFDA UDI	Class I	Active
Light	80401003	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246313	EUDAMED	Class I	Active
StarLock	ESSL52220-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21717-1IC	EUDAMEDFDA UDI	Class I	Active
Flex	81707320	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41921-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1313-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31313-1IC	EUDAMEDFDA UDI	Class I	Active
Prio	13425205	EUDAMED	Class I	Active
Standard Air	ESSCS1317-1	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA31919-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246104	EUDAMED	Class I	Active
Clean	80229294	EUDAMEDFDA UDI	Class I	Active
Xact	13250211	EUDAMED	Class I	Active
StarLock	ESSL20913-1IC	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1515-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41111-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126311	EUDAMED	Class I	Active
StarLock	ESSL51412-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13123117	EUDAMED	Class I	Active
Prio	13426513	EUDAMED	Class I	Active
Hi-Loo Fixed	80301106	EUDAMED	Class I	Active
StarLock	ESSL52020-1N	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1921-2	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126420	EUDAMED	Class I	Active
StarLock	ESSL41715-1N	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1715-1	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126114	EUDAMED	Class I	Active
StarLock	ESSL21521-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 6	13240213	EUDAMED	Class I	Active
Xact	13250202	EUDAMED	Class I	Active
Swift Mobil 24"-2	80229478	EUDAMED	Class I	Active
StarLock	ESSL31719-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL30911-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 5XL	13126315	EUDAMED	Class I	Active
StarLock	ESSL20909-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51216-1IC	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC1513-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246206	EUDAMED	Class I	Active
StarLock	ESSL21915-1	EUDAMEDFDA UDI	Class I	Active
Stapel	81204002	EUDAMED	Class I	Active
StarLock	ESSL31917-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31719-1IC	EUDAMEDFDA UDI	Class I	Active
Prio	13426509	EUDAMED	Class I	Active
StarLock	ESSL21719-1	EUDAMEDFDA UDI	Class I	Active
Alto	80229604	EUDAMED	Class I	Active

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