MDR-certified: APL and LL-Sets for the BodyGuard and LimLess® infusion pumps

01/19/2022

The pfmmedical group is proud to announce that it has been granted certification under the EU Medical Device Regulation for its product groups APL 2002® Set, infusion tubing sets for use with BodyGuard infusion pumps*, and the LL 2012 Set, infusion tubing for use with the LimLess® infusion pump. 

These premium quality medical devices, manufactured by pfm medical mepro gmbh, belong to the “Infusion systems and accessories” product group. Certification testing was carried out by DEKRA Certification GmbH in accordance with Regulation (EU) 2017/745. The BodyGuard and LimLess® infusion pumps, marketed by pfm medical tpm gmbh, form part of pfmmedical’s holistic solution concept for outpatient care. This concept consists of a coordinated suite of products and services that take into account the individual needs of users. 

“The fact that we have achieved certification so soon confirms that we are on the right track with our MDR strategy,” comments Stefanie Hafer, Managing Director of pfm medical tpm gmbh. Hafer goes on to emphasise: “This sends an important signal to our customers. Looking to the future, it is tied in with the message that, thanks to our MDR-certified products, we are in a position to guarantee reliable ongoing delivery of care to our patients.” The BodyGuard and LimLess® infusion pumps, each with their specific tubing sets, are used universally for infusion therapy. These portable electric infusion systems make it possible to provide complex care, including chemotherapy and pain therapy, antibiotic treatment and parenteral nutrition, in the home setting.

*BodyGuard 323 / 121 Twins / 545 ColorVision / 575 ColorVision / BD BodyGuard™