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.

The blood collection devices and the transfer filter set are expected to be available again from the end of 2026, and the vacuum bottles from mid-2027.

In order to be able to offer replacement products in the Vacuum Bottle segment, 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

 

 

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

No manufacturer available across the EU

not available

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

No manufacturer available across the EU

not available

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

No manufacturer available across the EU

not available

 

 

 

PPS vacuum bottles in the MDR authorisation process

 

PZN

Art.-Nr.: 50100250

PPS vacuum bottle 250 ml

03769563 (DE)
5480051 (AT)

Art.-Nr.: 50100500

PPS vacuum bottle 500 ml

03768434 (DE)
5480068 (AT)

Art.-Nr.: 50101250

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

5029385 (DE)
5480039 (DE)

Art.-Nr.: 50101251

PPS vacuum bottle 250 ml with 12 ml sodium citrate

09616116 (DE)
5480045 (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.

Welcome to MEDIPAC GmbH.

According to your system settings this website is displayed in English language.

Continue in English
اتصال سريع
  • Home