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 ccording to MDR

Transitional article

PZN

PPS Transfer-Filter-Set

Transfer-Filter-Set

 

Art.-Nr.: 42301026

Art.-Nr.: 42301126

5029416 (DE)

   

PPS Blood Collection Device

Transfer-Set 1,5 mm

 

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

Art.-Nr.: 42301125

19480988 (DE)
5917157 (AT)

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

Art.-Nr.: 42301125

19480988 (DE)
5917157 (AT)

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

Art.-Nr.: 42301125

19480988 (DE)
5917157 (AT)

 

 

 

PPS vacuum bottles in the MDR authorisation process

 

PZN

Art.-Nr.: 50100250

PPS vacuum bottle 250 ml

037 695 63 (DE)
548 005 1 (AT)

Art.-Nr.: 50100500

PPS vacuum bottle 500 ml

037 684 34 (DE)
548 006 8 (AT)

Art.-Nr.: 50101250

PPS vacuum bottle 250 ml with diffuser and 12 ml sodium citrate

502 938 5 (DE)
548 003 9 (DE)

Art.-Nr.: 50101251

PPS vacuum bottle 250 ml with 12 ml sodium citrate

096 161 16 (DE)
548 004 5 (AT)

 

 

 

SPM Vacuum Bottles for laboratory use

 

PZN

Art.-Nr.: 50000250

SPM vacuum bottle 250 ml

19540621 (DE)

Art.-Nr.: 50000500

SPM vacuum bottle 500 ml

19540615 (DE)

Art.-Nr.: 50001250

SPM vacuum bottle 250 ml with sodium citrate

19540644 (DE)

Art.-Nr.: 50002250

SPM vacuum bottle 250 ml with sodium citrate and diffuser

19540638 (DE)

   

 

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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