Question 1

What types of medical devices does FRELU GmbH manufacture?

Accepted Answer

FRELU GmbH specializes in grab bars and shower handrails designed for use in wet environments, such as bathrooms. These include standard-length grab bars (e.g., 600 mm, 800 mm, 2.320 mm, and 3.000 mm) and modular shower handrails, including customizable corner installations (e.g., 270° systems). Products are available in matte white or smooth finishes, with options for concealed or exposed mounting to accommodate different installation needs. These devices are intended to assist users with mobility and stability in sanitary rehabilitation settings.

Question 2

Where is FRELU GmbH based, and what regulatory standards do its devices follow?

Accepted Answer

FRELU GmbH is based in Germany. Its devices are classified under EU Medical Device Regulation Class I, which applies to low-risk, non-invasive medical devices like grab bars and shower handrails. Since these devices are intended for patient support and mobility assistance, they must comply with EU regulatory requirements for safety, performance, and conformity assessment. The company ensures its products meet these standards to ensure safe use in care environments such as hospitals, nursing homes, and sanitary rehabilitation facilities.

Question 3

Are FRELU GmbH’s devices listed in any regulatory registries, and why does this matter?

Accepted Answer

Yes, FRELU GmbH’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This listing confirms that the manufacturer has declared conformity with EU Medical Device Regulation (MDR) requirements for Class I devices. Listing in EUDAMED helps healthcare providers, regulators, and other stakeholders verify the legitimacy of the devices and ensures transparency about their regulatory status, which is particularly important for devices used in patient care settings like hospitals and nursing homes.

Question 4

How are FRELU GmbH’s grab bars and shower handrails classified under EU regulations?

Accepted Answer

FRELU GmbH’s grab bars and shower handrails fall under EU Medical Device Regulation (MDR) Class I, which is the lowest risk classification for medical devices. This classification applies because these products are non-invasive, intended for short-term or occasional use, and do not pose significant health risks when used as intended (e.g., providing support for mobility in wet areas). Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU safety and performance standards.

Catalogue129

Stützgriff 850 x 305 mm, rechts Ref SGD850RF

Stützklappgriff 600 mm, mit Standsäule und Bodenstütze 760, mit Toilettenpapierhalter Ref SKGSBS600TPF760

Winkelgriff 90°, 670 x 1.210 mm, glatt, verdeckte Montage Ref WG90-670X1210VG

Stützklappgriff 850 mm, mit Standsäule und Bodenstütze, mit Toilettenpapierhalter Ref SKGSBS850TPF

Winkelgriff FRELU-nach-Maß Baukastensystem 90° Winkel Ref WG90-SON

Stützklappgriff 500 mm, mit Bodenstütze 760 mm Ref SKGBS500F760

Stützklappgriff 500 mm, mit Bodenstütze Ref SKGBS500F

Winkelgriff 135°, 668 x 1.208 mm, glatt, verdeckte Montage Ref WG135-668X1208VG

Stützklappgriff 700 mm, mit Bodenstütze 760 mm Ref SKGBS700F760

Stützklappgriff 850 mm, mit Standsäule 760 mm, mit Toilettenpapierhalter Ref SKGS850TPF760

Stützklappgriff 700 mm, mit Standsäule 760 mm, mit Toilettenpapierhalter Ref SKGS700TPF760

Winkelgriff 90°, 305 x 610 mm, Links Ref WG305X610LF

Stützklappgriff 700 mm Ref SKG700F

Stützklappgriff 700 mm, mit Standsäule, mit Toilettenpapierhalter Ref SKGS700TPF

Stützklappgriff 850 mm, mit Standsäule und Bodenstütze Ref SKGSBS850F

Stützklappgriff 700 mm, mit Standsäule 760 mm Ref SKGS700F760

Stützklappgriff 850 mm, mit Bodenstütze Ref SKGBS850F

Stützklappgriff 600 mm, mit Standsäule 760 mm Ref SKGS600F760

Stützklappgriff 700 mm, mit Bodenstütze, mit Toilettenpapierhalter Ref SKGBS700TPF

Winkelgriff 90°, 305 x 305 mm Ref WG305X305F

Stützklappgriff 600 mm, mit Bodenstütze 760 mm, mit Toilettenpapierhalter Ref SKGBS600TPF760

Stützklappgriff 500 mm Ref SKG500F

Stützklappgriff 850 mm, mit Standsäule und Bodenstütze 760 mm Ref SKGSBS850F760

Stützklappgriff 700 mm, mit Bodenstütze Ref SKGBS700F

Stützklappgriff 850 mm, mit Bodenstütze, mit Toilettenpapierhalter Ref SKGBS850TPF

Winkelgriff 90°, 459 x 610 mm, Rechts Ref WG459X610RF

Winkelgriff 90°, 670 x 1.550 mm, glatt, offene Montage Ref WG90-670X1550G

Winkelgriff 135°, 668 x 668 mm, glatt, verdeckte Montage Ref WG135-668X668VG

Winkelgriff FRELU-nach-Maß Baukastensystem 90° Winkel Ref WG135-SON

Winkelgriff 45°, 680 x 1.060 mm, glatt, verdeckte Montage Ref WG45-680X1060VG

Winkelgriff 90°, 405 x 815 mm, Links Ref WG405X815LF

Winkelgriff 90°, 405 x 815 mm, Rechts Ref WG405X815RF

Winkelgriff 90°, 670 x 670 mm, glatt, verdeckte Montage Ref WG90-670X670VG

Winkelgriff 90°, 670 x 1.210 mm, glatt, offene Montage Ref WG90-670X1210G

Winkelgriff 45°, 680 x 680 mm, glatt, verdeckte Montage Ref WG45-680X680VG

Haltegriff 2.320 mm glatt Ref HG2320G

Duschhandlauf 760 x 760 mm, glatt, verdeckte Montage Ref RLK-760X760VG

Haltegriff 600 mm, Fingergriff, RAL9016 weiß, matt Ref HG600F-9016M

Duschhandlauf 1.650 x 1.650 mm, glatt, verdeckte Montage Ref HLK-1650X1650VG

Haltegriff 800 mm glatt Ref HG800G

Haltegriff 600 mm glatt Ref HG600G

Haltegriff 600 mm, Fingergriff, verdeckte Montage Ref HG600VF

Duschhandlauf 270° FRELU-nach-Maß Baukastensystem 270° Eckmontage, kundenspezifisches Maß (300 bis .. Ref HLK-SON

Haltegriff 2.320 mm glatt, verdeckte Montage Ref HG2320VG

Duschhandlauf 760 x 1.140 mm, glatt, offene Montage Ref RLK-760X1140G

Haltegriff 3.000 mm glatt Ref HG3000G

Haltegriff 800 mm, Fingergriff, verdeckte Montage Ref HG800VF

Duschhandlauf 770 x 770 mm, glatt, verdeckte Montage Ref HLK-770X770VG

Duschhandlauf 760 x 760 mm, glatt, offene Montage Ref RLK-760X760G

Haltegriff 600 mm, Fingergriff Ref HG600F

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