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
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
Aluminium Cane Folding 520 (grey)	RF-520/S	EUDAMED	Class I	Active
4-Wheeled Walker Palermo Premium 624 (grey)	RF-624/S	EUDAMED	Class I	Active
ANTI-DECUBITUS BASE MATTRESS RehaBASIC	RF-B1/10/BEN	EUDAMED	Class I	Active
ANTI-BEDSORE MATTRESS GOFER RehaComfortPro	RF-CP1/12/N	EUDAMED	Class I	Active
Opaska elastyczna stawu kolanowego "Alpha Knee"	AS-KL01/XL	EUDAMED	Class I	Active
ANTI-BEDSORE MATTRESS GOFER RehaComfortPro	RF-CP1/15/EN	EUDAMED	Class I	Active
Pas Brzuszny Przewiewny "24cm" Ventrimax Air	O-1401/XXL	EUDAMED	Class I	Active
Tetrapod (grey)	RF-400	EUDAMED	Class I	Active
Bed Backrest 950	RF-950	EUDAMED	Class I	Active
4-WHEELED WALKER Marsylia (GRAPHITE)	RF-617	EUDAMED	Class I	Active
Wózek Inwalidzki Cruiser Utilis (szary)	RF-11/48/PU/S/T	EUDAMED	Class I	Active
Aluminium Cane (red)	RF-510/C	EUDAMED	Class I	Active
Shower Chair – Nathan 820	RF-820	EUDAMED	Class I	Active
Anti-Bedsore Seat Cushion	BioFlote 2 Plus	EUDAMED	Class I	Active
Senyo LegLong long leg spacer	SN-02/LLG-L	EUDAMED	Class I	Active
STANDALONE ANTI-DECUBITUS MATTRESS RehaComfort	RF-C1/15/EN	EUDAMED	Class I	Active
Cotton Waterproof Elastic Cover	15/P/BEN/7/B	EUDAMED	Class I	Active
Opaska elastyczna stawu skokowego „Alpha Ankle”	AS-SK01/S	EUDAMED	Class I	Active
Nasadka Toaletowa Kate 871	RF-871/15	EUDAMED	Class I	Active
Senyo Lift 60 pad	SN-02/LIFT	EUDAMED	Class I	Active
Orteza stopowo-goleniowa “AIR WALKER DUOSHELL” LONG	O-1186/XS	EUDAMED	Class I	Active
Aluminium Cane (grey)	RF-510/S	EUDAMED	Class I	Active
Bathtub Seat – Emma 851	RF-851	EUDAMED	Class I	Active
Orteza Stawu Skokowego "malleomax Pro"	O-1161/L	EUDAMED	Class I	Active
Pas Lędźwiowo-Krzyżowy Z Pasami Dociągowymi "lumbomax Plus"	O-1431/S	EUDAMED	Class I	Active
Senyo Head anti-bedsore head pad	SN-02/HEA-L	EUDAMED	Class I	Active
Wheelchair Rf-4 Cruiser Active 2 Z (black)	RF-4-Z/42/PU/CZA-624/PU	EUDAMED	Class I	Active
4-Wheeled Walker Bogota Premium 625(grey)	RF-625	EUDAMED	Class I	Active
Aluminium Cane Folding 520 (green)	RF-520/Z	EUDAMED	Class I	Active
Adjustable Bathtub Seat – Ava 853	RF-853	EUDAMED	Class I	Active
Aluminium Cane (black)	RF-510/CZA	EUDAMED	Class I	Active
Elbow Crutch (gren)	RF-220/Z	EUDAMED	Class I	Active
Wózek Inwalidzki Rf-1 Cruiser 1 (szary)	RF-1/48/PN/S-624/PU	EUDAMED	Class I	Active
Wózek Inwalidzki Cruiser Active (czarny)	RF-3/45/PU/CZA-624/PU	EUDAMED	Class I	Active
Temblak Kończyny Górnej Siatkowy Różowy	O-1501/R/S	EUDAMED	Class I	Active
3-Wheeled Walker Barcelona 611 (grey)	RF-611/S	EUDAMED	Class I	Active
Uchwyt Łazienkowy Prosty Cezar 911	RF-911/70	EUDAMED	Class I	Active
Ózek Inwalidzki Cruiser Liber (biały)	RF-20/45/PU/B-624/PU	EUDAMED	Class I	Active
SUPPORTING PILLOW Senyo Assist	SN-02/AST	EUDAMED	Class I	Active
ANTI-BEDSORE MATTRESS GOFER RehaComfortPro	RF-CP1/10/EN	EUDAMED	Class I	Active
Wózek Inwalidzki Rf-1 Cruiser 1 (szary)	RF-1/45/PN/S-624/PU	EUDAMED	Class I	Active
Opaska elastyczna stawu kolanowego "Alpha Knee"	AS-KL01/S	EUDAMED	Class I	Active

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