This is to inform you of 2 changes affecting the Ramboldi single use plastics portfolio.
1. Change in CE Status
We would like to update you on the classification of a number of items within the Ramboldi single use plastics portfolio, in accordance with the In Vitro Diagnostic Medical Device Directive 98/79/EC.
It has been noted that two product ranges, Plastic Pasteur Pipettes and Centrifuge Tubes, have been incorrectly classified and CE marked under the In Vitro Diagnostic Medical Device Directive 98/79/EC. Only products which satisfy the regulatory requirements are permitted to carry the CE IVD mark.
Although there has been some confusion over the years as to whether some items should carry the CE mark, it has always been clear that products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination. In all documentation supporting the directive it is made clear that both transfer pipettes and centrifuge tubes are not permitted to carry the CE IVD mark as they are for general laboratory use and are not specifically intended to be used for in vitro diagnostic examination.
With immediate effect, the Plastic Pasteur Pipettes and Centrifuge Tube products indicated in the attached table will no longer fall under the scope of in vitro diagnostic medical devices in accordance to the In Vitro Diagnostic Directive 98/79/EC and so will no longer carry the CE mark once current stocks are depleted. We would like to reassure you the product will continue to be manufactured to the same exacting standards as it is currently, and although classed as general laboratory products, can still be used to perform in vitro diagnostic procedures where necessary.
2. Transition in brand from Ramboldi® to WHEATON®.
As of the 6th July 2020 SciLabware Limited will be changing its name to DWK Life Sciences Limited. The name change is to align SciLabware Limited with the rest of the DWK Life Sciences Group. The DWK Life Sciences group represents many key glassware and plastic brands within the scientific industry, such as Pyrex, Duran and Wheaton to name but a few. To enable us to best support our key brands going forward we have taken the decision to re-brand our Ramboldi single use plastic products as Wheaton. This will be a gradual process and start to impact product manufactured from July onwards.
The products affected by this are detailed in the attached table. The only change being made is label artwork. The most noticeable changes will be with the specimen container range where branding artwork on both the container label and outer carton will change.
There will be no change to the pricing, manufacture, product codes, product specification and form fit or function. This will simply be a branding activity.
Please can you update your product listings on your internal systems and website to reflect these changes. The new Wheaton logo can be found in our DAM accessed via the DWK Life Sciences website, or by clicking on the following link.