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
Water-Resistant Cover	15/P/PVC/15	EUDAMED	Class I	Active
Orthopedic Pillow Morfeusz Delicate 664	664	EUDAMED	Class I	Active
Senyo LegLong long leg spacer	SN-02/LLG-S	EUDAMED	Class I	Active
Toilet Seat – Louis 840 (black)	RF-840/CZA	EUDAMED	Class I	Active
Pas Lędźwiowo-Krzyżowy Z Pasami Dociągowymi "lumbomax Plus"	O-1431/M	EUDAMED	Class I	Active
Uchwyt Łazienkowy Prosty Cezar 911	RF-911/60	EUDAMED	Class I	Active
Elastic, Waterproof Sheet	15/P/EN	EUDAMED	Class I	Active
Wózek Inwalidzki Cruiser Active Z (czarny)	RF-3-Z/48/PN/CZA-624/PU	EUDAMED	Class I	Active
Pas Brzuszny "24cm" Ventrimax	O-1400/S	EUDAMED	Class I	Active
4-WHEELED WALKER Marsylia (GOLD)	RF-617/Ż	EUDAMED	Class I	Active
Elbow Crutch (red)	RF-220/C	EUDAMED	Class I	Active
Neoprenowy Stabilizator Stawu Kolanowego Ligamax Knee	O-1201/2	EUDAMED	Class I	Active
Bathtub Bench With Backrest Amber	RF-830	EUDAMED	Class I	Active
Orteza stopowo-goleniowa ″AIR WALKER DUOSHELL″ SHORT	O-1187/XL	EUDAMED	Class I	Active
Wheelchair Rf-4 Cruiser Active 2 (grey)	RF-4/42/PU/S-624/PU	EUDAMED	Class I	Active
Opaska elastyczna stawu nadgarstkowego "Alpha Wrist Pro"	AS-NK01/L	EUDAMED	Class I	Active
Pas Brzuszny "24cm" Ventrimax Czarny	O-1400/CZA/L	EUDAMED	Class I	Active
Pas Pachwinowo-Przepuklinowy Jednostronny ‘axilmax’	O-1408/M/L	EUDAMED	Class I	Active
4-Wheeled Walker	RF-610/N	EUDAMED	Class I	Active
3-Wheeled Walker Genewa Premium 622	RF-622	EUDAMED	Class I	Active
Elastyczny Stabilizator Stawu Kolanowego Z Zawiasami Genumax Plus	O-1210/S	EUDAMED	Class I	Active
Tutor Stawu Kolanowego „immobimax”	O-1250/M	EUDAMED	Class I	Active
Toilet Safety Rail Judy 940	RF-940	EUDAMED	Class I	Active
Elastyczny Stabilizator Stawu Kolanowego Z Zawiasami Genumax Plus	O-1210/L	EUDAMED	Class I	Active
Rehabilitation Bed Cama	RF-2000	EUDAMED	Class I	Active
Wheelchair Rf-4 Cruiser Active 2 Z (grey)	RF-4-Z/42/PN/S-624/PU	EUDAMED	Class I	Active
Walking Frame Harry With Seat And Toilet Set 133	RF-133/S	EUDAMED	Class I	Active
4-Wheeled Walker Oslo Premium 616 (grey)	RF-616/S	EUDAMED	Class I	Active
ANTI-BEDSORE MATTRESS GOFER RehaComfortPro	RF-CP1/15/N	EUDAMED	Class I	Active
Opaska elastyczna stawu skokowego „Alpha Ankle”	AS-SK01/L	EUDAMED	Class I	Active
Wheelchair Cruiser Active Z (black)	RF-3-Z/42/PN/CZA-624/PU	EUDAMED	Class I	Active
Walking Frame Rf-100 Black	RF-100/CZA	EUDAMED	Class I	Active
Aluminium Cane Folding 520 (brown)	RF-520/BR	EUDAMED	Class I	Active
Pas Lędźwiowo-Krzyżowy "lumbomax" Czarny	O-1430/CZA/XL	EUDAMED	Class I	Active
STANDALONE ANTI-DECUBITUS MATTRESS RehaComfort	RF-C1/10	EUDAMED	Class I	Active
Water-Resistant Cover	15/P/PVC/7	EUDAMED	Class I	Active
Waterproof Cover	15/P/PVC/12	EUDAMED	Class I	Active
Temblak Kończyny Górnej Siatkowy Czarny	O-1501/CZA/XL	EUDAMED	Class I	Active
Elastyczny Stabilizator Stawu Kolanowego Z Osłoną Silikonową I Stalkami Genumax	O-1211/M	EUDAMED	Class I	Active
Wózek Inwalidzki Cruiser Active Z (czarny)	RF-3-Z/51/PN/CZA-624/PU	EUDAMED	Class I	Active
Pas Brzuszny "24cm" Ventrimax	O-1400/L	EUDAMED	Class I	Active
Orteza stopowo-goleniowa ″AIR WALKER DUOSHELL″ SHORT	O-1187/S	EUDAMED	Class I	Active
Bathtub Seat Olivia 855	RF-855	EUDAMED	Class I	Active
Head Pillow	PPP1937/7	EUDAMED	Class I	Active
Elastyczny Stabilizator Stawu Kolanowego Z Osłoną Silikonową I Stalkami Genumax	O-1211/S	EUDAMED	Class I	Active
Wheelchair Rf-4 Cruiser Active 2 Z (grey)	RF-4-Z/45/PN/S-624/PU	EUDAMED	Class I	Active
Aluminium Cane (blue)	RF-510/N	EUDAMED	Class I	Active
Raised Toilet Seat – Sara 870	RF-870/10	EUDAMED	Class I	Active
Flip-Up Toilet Support Rail Daniel 920	RF-920	EUDAMED	Class I	Active
Orteza ręki i przedramienia z ujęciem kciuka ″FlexLoopT″	O-1751/S/L	EUDAMED	Class I	Active

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