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	ESSL51412-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESMC1311-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41511-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31715-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL42119-1	EUDAMEDFDA UDI	Class I	Active
Swift Mobil-2	80229401	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21315-1	EUDAMEDFDA UDI	Class I	Active
Prio	13424605	EUDAMED	Class I	Active
Standard Air	ESMC1915-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41917-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31517-1	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246014	EUDAMED	Class I	Active
StarLock	ESSL51616-1	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA32117-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSCS1113-1	EUDAMEDFDA UDI	Class I	Active
Prio	13423213	EUDAMED	Class I	Active
Prio	13423413	EUDAMED	Class I	Active
Prio	13425905	EUDAMED	Class I	Active
StarLock	ESSL41109-1N	EUDAMEDFDA UDI	Class I	Active
Cross 5	13123015-R	EUDAMED	Class I	Active
Standard Air	ESSC0909-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL22117-1IC	EUDAMEDFDA UDI	Class I	Active
Prio	13425913	EUDAMED	Class I	Active
Aktiv	80505003	EUDAMEDFDA UDI	Class I	Active
Relax	81703060	EUDAMEDFDA UDI	Class I	Active
Prio	13423205	EUDAMED	Class I	Active
Cross 6	13243113	EUDAMED	Class I	Active
Swift	81701610	EUDAMEDFDA UDI	Class I	Active
StabilAir	ESSA31719-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL32121-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL41717-1	EUDAMEDFDA UDI	Class I	Active
Clean	80229281	EUDAMED	Class I	Active
Fresh	81600011	EUDAMEDFDA UDI	Class I	Active
Prio	13423717	EUDAMED	Class I	Active
Fresh	81600024	EUDAMEDFDA UDI	Class I	Active
Swift Mobil-2	80229477	EUDAMED	Class I	Active
StarLock	ESSL41719-1	EUDAMEDFDA UDI	Class I	Active
Standard Air	ESSC2117-1	EUDAMEDFDA UDI	Class I	Active
Crissy	13230207	EUDAMED	Class I	Active
Cross 6	13246211	EUDAMED	Class I	Active
StarLock	ESSL51622-1N	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31517-1IC	EUDAMEDFDA UDI	Class I	Active
Cross 6	13246303	EUDAMED	Class I	Active
StarLock	ESSL32117-1IC	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL51418-1IZ	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL21109-1IC	EUDAMEDFDA UDI	Class I	Active
Cross	13120104-R	EUDAMED	Class I	Active
Cross 6	13240108	EUDAMED	Class I	Active
Standard Air	ESMC1317-1	EUDAMEDFDA UDI	Class I	Active
StarLock	ESSL31115-1IC	EUDAMEDFDA UDI	Class I	Active

ETAC SUPPLY CENTER AB

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