Approval of our medical devices according to MDR - Availability

Some of our medical devices may only be sold after approval in accordance with the Medical Device Regulation (MDR). These are the PPS Transfer-Filter-Set, the PPS Blood Collection Devices and the PPS Vacuum Bottles in their various versions.

Nevertheless, in order to ensure market supply, we have been able to include alternative products for the PPS Blood Collection Devices and the PPS Transfer Filter Set in our range, which will be available until the expected approval of the usual products in 2025.

In order to be able to offer replacement products in the Vacuum Bottle segment as well, we have introduced a complete range of SPM Vacuum Bottles. SPM stands for “Sterile Packaging Material”. These SPM Vacuum Bottles are intended for use in the laboratory and are therefore not CE marked. In order to offer the SPM Vacuum Bottles at the highest quality level, the production process and the corresponding tests are exactly the same as for our original medical products.

Product in approval according to MDR

Transitional article

PPS Transfer-Filter-Set

Art.-Nr.: 42301026

Transfer-Filter-Set

Art.-Nr.: 42301126

PPS Blood Collection Devices

Art.-Nr.: 42301025 (1,5 mm)

Art.-Nr.: 42301031 (1,8 mm)

Art.-Nr.: 42301027 (1,8 mm with roll clamp)

Blood Collection Device

Art.-Nr.: 42301125 (1,5 mm)

Art.-Nr.: 42301125 (1,5 mm)

Art.-Nr.: 42301125 (1,5 mm)

  

Product in approval according to MDR

Transitional article for laboratory use

PPS Vacuum Bottles

 

Art.-Nr.: 50100250

Art.-Nr.: 50100500

Art.-Nr.: 50101250

Art.-Nr.: 50101251

SPM Vacuum Bottles

Sterile packaging for laboratory use

50000250 (250 ml)

50000500 (500 ml)

50001250 (250 ml with sodium citrate)

50002250 (250 ml with sodium citrate and diffuser)

 

MediPac GmbH endeavors to supply the trade. We therefore kindly ask you to contact your usual retail partners directly if you are interested in our products and the temporary replacement products.

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