Question 1

What types of medical devices does Oxford Medical Healthcare Limited manufacture?

Accepted Answer

Oxford Medical Healthcare Limited specialises in incontinence and continence support products for adults. Their portfolio includes full-body support loops, toileting aids, and various sling designs. These devices are designed to provide support for continence management, such as solid and net slings in different sizes and configurations, as well as reflex and multifit systems tailored to specific user needs.

Question 2

Where is Oxford Medical Healthcare Limited based?

Accepted Answer

Oxford Medical Healthcare Limited is based in the United Kingdom (UK). This location is relevant for regulatory compliance and distribution within the EU and globally.

Question 3

Which regulatory registries list Oxford Medical Healthcare Limited’s devices?

Accepted Answer

Oxford Medical Healthcare Limited’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry is used to track and monitor medical devices authorised under EU Medical Device Regulations.

Question 4

How are Oxford Medical Healthcare Limited’s devices classified under EU regulations?

Accepted Answer

All of Oxford Medical Healthcare Limited’s listed devices fall under Class I classification according to the EU Medical Device Regulation (MDR). This classification is typically assigned to low-risk devices, such as incontinence and continence support products, which pose minimal risk to users when used as intended.

Device	Model / Reference	Registries	Class	Status
Sling, Oxford Fullback, X-Large	SL1071	EUDAMED	Class I	Active
Sling, Fullback, Net, Large	SL1083	EUDAMED	Class I	Active
Oxford Quickfit Spacer-Medium	SL1402	EUDAMED	Class I	Active
Fullbody Amputee Poly XL	SL1204-NL	EUDAMED	Class I	Active
Sling, Access, Solid, Medium, W/O Ts	SL1642	EUDAMED	Class I	Active
Sling, Multifit, Size 3	SL1582	EUDAMED	Class I	Active
Sling, Standing, Disp, Small	SL13525N	EUDAMED	Class I	Active
Full Body (Loop) (XL) - Net, Netherlands	SL1780-NL	EUDAMED	Class I	Active
Multifit Reflex Sl Size 8	SL1728	EUDAMED	Class I	Active
Sling, Fullback, Net, Small	SL1081	EUDAMED	Class I	Active
Full Body (Loop) (XS) - Net, Netherlands	SL1776-NL	EUDAMED	Class I	Active
Sling, Standing Dlux, Solid, Medium	SL13500N	EUDAMED	Class I	Active
Oxford Elara 2 Way 227kg	OXF-ELARA2-227	EUDAMED	Class I	Active
Sling, Qfit Dlux, Solid, Medium	SL1053	EUDAMED	Class I	Active
OXF Full Body Net w Loops Large	SL1779	EUDAMED	Class I	Active
Sling, Bariatric, Spacer, 2xl	SL1031	EUDAMED	Class I	Active
Sling, Multifit, Size 1	SL1580	EUDAMED	Class I	Active
Sling, Access With Hd Xl	SL1629	EUDAMED	Class I	Active
Sling, Qfit, Solid, Medium	SL1003	EUDAMED	Class I	Active
Oxford Ultrafine Reflex XL	SL1534	EUDAMED	Class I	Active
Sling, L/S Plain, Net, Large	SL1107	EUDAMED	Class I	Active
Multifit Sl Size 10	SL1549	EUDAMED	Class I	Active
Deluxe Standing Sling, XL	SL13497N	EUDAMED	Class I	Active
Multifit Sl Size 4	SL1543	EUDAMED	Class I	Active
Sling, Access, Solid, Small, W/O Ts	SL1641	EUDAMED	Class I	Active
OXF Full Body Solid w Loops Large	SL1774	EUDAMED	Class I	Active
Sling, Transport Dlux, Solid, Small	SL13502N	EUDAMED	Class I	Active
Fullbody Amputee Poly M	SL1202-NL	EUDAMED	Class I	Active
Multifit Reflex Sl Size 10	SL1730	EUDAMED	Class I	Active
Sling, Qfit, Solid, Large	SL1006	EUDAMED	Class I	Active
Sling, Oxford High Back , Medium	SL1765	EUDAMED	Class I	Active
Multifit Reflex Size 1	SL1701	EUDAMED	Class I	Active

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