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
Pas Brzuszny "24cm" Ventrimax Czarny	O-1400/CZA/S	EUDAMED	Class I	Active
BASE AND STANDALONE MATTRESS RehaStandard	RF-S1/10	EUDAMED	Class I	Active
STANDALONE ANTI-DECUBITUS MATTRESS RehaComfort	RF-C1/12	EUDAMED	Class I	Active
Pas Lędźwiowo-Krzyżowy "lumbomax"	O-1430/M	EUDAMED	Class I	Active
Wózek Inwalidzki Cruiser Active (czarny)	RF-3/48/PU/CZA-624/PU	EUDAMED	Class I	Active
Poduszka Przeciwodleżynowa Do Siedzenia	BioFlote 2 Plus /45	EUDAMED	Class I	Active
Uchwyt Łazienkowy Prosty Cezar 911	RF-911/40	EUDAMED	Class I	Active
Wózek Inwalidzki Rf-1-B Cruiser 1 Basic (szary)	RF-1-B/42/PN/S/U	EUDAMED	Class I	Active
Temblak Kończyny Górnej Siatkowy Różowy	O-1501/R/M	EUDAMED	Class I	Active
Hygienic Underpad For Home Care	3046-11/N	EUDAMED	Class I	Active
Tripod (grey)	RF-300	EUDAMED	Class I	Active
Temblak Kończyny Górnej Siatkowy Różowy	O-1501/R/XL	EUDAMED	Class I	Active
Orteza Wielopalcowa Ręki ‘digimax’	O-1770/L/P	EUDAMED	Class I	Active
Temblak Kończyny Górnej Siatkowy Czarny	O-1501/CZA/L	EUDAMED	Class I	Active
Bathtub Support Rail – Denis 900	RF-900	EUDAMED	Class I	Active
Wózek Inwalidzki Cruiser Liber (biały)	RF-20/48/PU/B-624/PU	EUDAMED	Class I	Active
Heelchair Rf-1-B Cruiser 1 Basic (grey)	RF-1-B/42/PN/S	EUDAMED	Class I	Active
Hygienic Underpad	3045-1/N	EUDAMED	Class I	Active
Pas Pachwinowo-Przepuklinowy Obustronny “axilmax Duo”	O-1409/L	EUDAMED	Class I	Active
Laska Aluminiowa Składana 520 (czerwona)	RF-520/C	EUDAMED	Class I	Active
Walking Frame Rf-100 Grey	RF-100/S	EUDAMED	Class I	Active
Aluminium Cane (green)	RF-510/Z	EUDAMED	Class I	Active
Senyo Ring anti-bedsore ring cushion	SN-02/RIN-3	EUDAMED	Class I	Active
Temblak Kończyny Górnej Siatkowy Czarny	O-1501/CZA/XS	EUDAMED	Class I	Active
Orteza Stawu Skokowego "malleomax"	O-1160/L	EUDAMED	Class I	Active
Uchwyt Łazienkowy Prosty Cezar 911	RF-911/30	EUDAMED	Class I	Active
Pas Pachwinowo-Przepuklinowy Jednostronny ‘axilmax’ Czarny	O-1408/CZA/L/P	EUDAMED	Class I	Active
ORTHOPEDIC PILLOW Senyo Basic	SN-01	EUDAMED	Class I	Active
Pas Lędźwiowo-Krzyżowy "lumbomax" Czarny	O-1430/CZA/M	EUDAMED	Class I	Active
Neoprenowy Stabilizator Nadgarstka Z Ujęciem Ręki Ligamax Palm	O-1721/U	EUDAMED	Class I	Active
Elastyczny Stabilizator Stawu Kolanowego Z Osłoną Silikonową I Stalkami Genumax	O-1211/XL	EUDAMED	Class I	Active
Waterproof Cover	15/P/N/12	EUDAMED	Class I	Active
Neoprenowy Stabilizator Nadgarstka Ligamax Wrist	O-1720/U	EUDAMED	Class I	Active
Round Shower Stool Cameron 822 (white)	RF-822/B	EUDAMED	Class I	Active
Pas Brzuszny Przewiewny "24cm" Ventrimax Air Czarny	O-1401/CZA/L	EUDAMED	Class I	Active
Pas Brzuszny Przewiewny "24cm" Ventrimax Air Czarny	O-1401/CZA/XXL	EUDAMED	Class I	Active
Flat Slipper Bed Pan (white)	RF-896/B	EUDAMED	Class I	Active
Bathtub Seat – Diana 856	RF-856	EUDAMED	Class I	Active
Opaska elstyczna stawu łokciowego "Alpha Elbow"	AS-ŁK01/S	EUDAMED	Class I	Active
Funkcjonalna Orteza Stawu Kolanowego ”duomax”	O-1280/S/L	EUDAMED	Class I	Active
Orthopedic Pillow Morfeusz Comfort 661	661	EUDAMED	Class I	Active
Basen Płaski Sanitarny (niebieski)	RF-896/N	EUDAMED	Class I	Active
Mobile Lift Seat With A Head Support	RF-1011/L	EUDAMED	Class I	Active
Rotor with display	RF-904	EUDAMED	Class I	Active
Slipper Bed Pan (white)	RF-892	EUDAMED	Class I	Active
Shower Stool – Kevin 821	RF-821	EUDAMED	Class I	Active
Cotton Waterproof Elastic Cover	15/P/BEN/10/B	EUDAMED	Class I	Active
Opaska elastyczna stawu skokowego „Alpha Ankle”	AS-SK01/XL	EUDAMED	Class I	Active
Hygienic Underpad	3045-6/N	EUDAMED	Class I	Active
Mobile Lift Newton	RF-1000	EUDAMED	Class I	Active

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