Question 1

What types of medical devices does REHA FUND Sp. z o.o. manufacture?

Accepted Answer

REHA FUND Sp. z o.o. specialises in mobility aids and rehabilitation equipment. Their product range includes non-foldable walking chairs, basic electric hospital beds, and ankle/foot orthoses. They also produce reusable abdominal hernia trusses, semi-rigid lumbar supports with adjustable straps (like the LumboMax Stabil), and elastic wrist stabilisers for thumb and carpal support. Additionally, they offer hydrotherapy baths/tanks for therapeutic use.

Question 2

Where is REHA FUND Sp. z o.o. based?

Accepted Answer

REHA FUND Sp. z o.o. is based in Warsaw, Poland. The company’s location in Poland aligns with its focus on manufacturing and supplying medical and rehabilitation devices within the European market.

Question 3

Which regulatory registries list REHA FUND Sp. z o.o.’s devices?

Accepted Answer

REHA FUND Sp. z o.o.’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registry ensures transparency and traceability of devices authorised under EU regulations.

Question 4

How are REHA FUND Sp. z o.o.’s devices classified under EU regulations?

Accepted Answer

All of REHA FUND Sp. z o.o.’s devices fall under EU Class I classification. This classification applies to low-risk medical devices, such as mobility aids, orthoses, and certain rehabilitation equipment, which typically require less stringent regulatory oversight than higher-risk categories.

Question 5

What distinguishes REHA FUND Sp. z o.o.’s reusable abdominal hernia trusses from other similar products?

Accepted Answer

REHA FUND Sp. z o.o. produces reusable abdominal hernia trusses, which are designed to provide external support for hernia management. Unlike single-use alternatives, their reusable models prioritise sustainability and cost-effectiveness for long-term patient use. These trusses are classified as Class I devices, reflecting their relatively low risk profile while still meeting medical support needs.

Device	Model / Reference	Registries	Class	Status
Orteza stopowo-goleniowa “AIR WALKER DUOSHELL” LONG	O-1186/L	EUDAMED	Class I	Active
ANTI-BEDSORE MATTRESS GOFER RehaComfortPro	RF-CP1/12/BEN	EUDAMED	Class I	Active
Anti-Bedsore Seat Cushion	BioFlote 3PLUS/43	EUDAMED	Class I	Active
Toilet Seat Michael 805	RF-805	EUDAMED	Class I	Active
Elbow Crutch (grey)	RF-200	EUDAMED	Class I	Active
Orteza Wielopalcowa Ręki ‘digimax’	O-1770/M/P	EUDAMED	Class I	Active
Pas Pachwinowo-Przepuklinowy Jednostronny ‘axilmax’	O-1408/S/P	EUDAMED	Class I	Active
Seat Cushion Komfort	RF-K1/PU	EUDAMED	Class I	Active
Wózek Inwalidzki Rf-1-B Cruiser 1 Basic (szary)	RF-1-B/45/PN/S	EUDAMED	Class I	Active
SmartGo ELECTRIC WHEELCHAIR	RF-35	EUDAMED	Class I	Active
ANTI-BEDSORE MATTRESS GOFER RehaComfortPro	RF-CP1/12	EUDAMED	Class I	Active
Aluminium Cane Folding 520 (black)	RF-520/CZA	EUDAMED	Class I	Active
Wheelchair Cruiser Smart (grey-Red)	RF-7/45/PN/S/CT	EUDAMED	Class I	Active
Basen Płaski Sanitarny (zielony)	RF-896/Z	EUDAMED	Class I	Active
Wheelchair Rf-4 Cruiser Active 2 (black)	RF-4/48/PU/CZA-624/PU	EUDAMED	Class I	Active
Wózek Inwalidzki Cruiser Active Z (czarny)	RF-3-Z/45/PN/CZA-624/PU	EUDAMED	Class I	Active
Uchwyt Łazienkowy Prosty Cezar 911	RF-911/90	EUDAMED	Class I	Active
Hygienic Underpad For Home Care	3046-1/N	EUDAMED	Class I	Active
Pas Brzuszny Przewiewny "24cm" Ventrimax Air Czarny	O-1401/CZA/M	EUDAMED	Class I	Active
4-Wheeled Walker Denver Premium 615 (red)	RF-615/S	EUDAMED	Class I	Active
Wózek Inwalidzki Cruiser Active (czarny)	RF-3/42/PU/CZA-624/PU	EUDAMED	Class I	Active
Orthopedic Pillow Morfeusz Exclusive 662	662	EUDAMED	Class I	Active
Temblak Kończyny Górnej	O-1500/XL	EUDAMED	Class I	Active
Wheelchair Cruiser Areo (black)	RF-6/42/PN/CZA-624/PU	EUDAMED	Class I	Active
Kidney Dish	RF-894	EUDAMED	Class I	Active
ANTI-BEDSORE MATTRESS GOFER RehaComfortPro	RF-CP1/10	EUDAMED	Class I	Active
Orteza ręki i przedramienia z ujęciem kciuka ″FlexLoopT″	O-1751/XL/P	EUDAMED	Class I	Active
Female Urinal Bottle	RF-891	EUDAMED	Class I	Active
4-Wheeled Walker Lizbona Premium 620 (red)	RF-620/C	EUDAMED	Class I	Active
4-Wheeled Walker	RF-610/C	EUDAMED	Class I	Active
Wózek Inwalidzki Rf-1 Cruiser 1 (szary)	RF-1/51/PN/S-624/PU	EUDAMED	Class I	Active
Opaska elastyczna stawu kolanowego "Alpha Knee"	AS-KL01/M	EUDAMED	Class I	Active
4-Wheeled Walker Berlin (graphite)	RF-626	EUDAMED	Class I	Active
Aluminum Reclining Wheelchair – Cruiser Utilis (grey)	RF-11/42/PN/S/T	EUDAMED	Class I	Active
Underarm Crutch (grey)	RF-230	EUDAMED	Class I	Active
ANTI-BEDSORE MATTRESS GOFER RehaComfortPro	RF-CP1/15/BEN	EUDAMED	Class I	Active
Temblak Kończyny Górnej Siatkowy Różowy	O-1501/R/L	EUDAMED	Class I	Active
Opaska elastyczna stawu nadgarstkowego "Alpha Wrist"	AS-NR01/M	EUDAMED	Class I	Active
Uchwyt Łazienkowy Prosty Cezar 911	RF-911/100	EUDAMED	Class I	Active
Wózek Inwalidzki Cruiser Active (czarny)	RF-3/51/PN/CZA-624/PU	EUDAMED	Class I	Active
Orteza ręki i przedramienia „FlexLoop”	O-1750/S-M	EUDAMED	Class I	Active
Miska Nerkowata	RF-894/2	EUDAMED	Class I	Active
Temblak Kończyny Górnej Siatkowy Niebieski	O-1501/N/M	EUDAMED	Class I	Active
Funkcjonalna Orteza Stawu Kolanowego ”duomax”	O-1280/XL/L	EUDAMED	Class I	Active
Personal Hygiene Chair – Oliwier 810	RF-810	EUDAMED	Class I	Active
Uchwyt Łazienkowy Prosty Cezar 911	RF-911/80	EUDAMED	Class I	Active
Pas Brzuszny "24cm" Ventrimax	O-1400/M	EUDAMED	Class I	Active
4-Wheeled Walker	RF-610/S	EUDAMED	Class I	Active
Jednoszynowa Orteza Stawu Kolanowego „monomax”	O-1260/P	EUDAMED	Class I	Active
Wózek Inwalidzki Cruiser Smart (szaro-Czerwony)	RF-7/45/PU/S/CT	EUDAMED	Class I	Active

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