Question 1

What types of medical devices does REBACARE B.V. manufacture?

Accepted Answer

REBACARE B.V. specialises in disposable hygiene covers and accessories for medical positioning devices. This includes stretch and cotton covers for products like DuoRole, TrioRole, and Multi64, as well as nicky covers for devices such as Crescent, Luna Pearl, and Support. Additionally, they produce ear tubes and cotton covers for Free Ear products. All these items are designed for single-use medical applications.

Question 2

Where is REBACARE B.V. based?

Accepted Answer

REBACARE B.V. is based in the Netherlands. The company’s location is relevant for understanding its regulatory framework and operational reach within the EU.

Question 3

Are REBACARE B.V.’s devices listed in any regulatory registries?

Accepted Answer

Yes, REBACARE B.V.’s devices are registered in the euDaMed database, which is the official EU registry for medical devices. This listing ensures transparency and traceability of their products under EU medical device regulations.

Question 4

How are REBACARE B.V.’s devices classified under EU regulations?

Accepted Answer

REBACARE B.V.’s devices are classified as Class I medical devices. This classification is determined by their intended use and risk level, with Class I devices generally posing the lowest risk and often requiring less stringent regulatory oversight than higher-class devices.

Device	Model / Reference	Registries	Class	Status
Comfort	77710	EUDAMED	Class I	Active
Cover stretch for FlexieXL	77727XL+HKS	EUDAMED	Class I	Active
Cover cotton for Maxima	7777+HK	EUDAMED	Class I	Active
Cover stretch for Forma	77716+HKS	EUDAMED	Class I	Active
Turnability	7775	EUDAMED	Class I	Active
Cover stretch for Luna Pearl	77721+HKS	EUDAMED	Class I	Active
Duorole	77788	EUDAMED	Class I	Active
Cover cotton for Role	7778+HK	EUDAMED	Class I	Active
Forma	77716	EUDAMED	Class I	Active
Cover stretch for Support	7779+HKS	EUDAMED	Class I	Active
Cover nicky for Forma	77716+H	EUDAMED	Class I	Active
Cover stretch for FlexieAbductie	77727+HKS	EUDAMED	Class I	Active
Maxima	7777	EUDAMED	Class I	Active
Cover nicky for Twister	77715+H	EUDAMED	Class I	Active
Cover stretch for Multi64	77726+HKS	EUDAMED	Class I	Active
Cover stretch for Multi54	77725+HKS	EUDAMED	Class I	Active
Cover stretch for ComfortXL	77710XL+HKS	EUDAMED	Class I	Active
Cover nicky for TrioRole	777888+H	EUDAMED	Class I	Active
Cover Nicky for Maxima	7777+H	EUDAMED	Class I	Active
Cover nicky for Multi54	77725+H	EUDAMED	Class I	Active
Rebacare verbandschoen	7771	EUDAMED	Class I	Active
Cover cotton for Comfort	77710+HK	EUDAMED	Class I	Active

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