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New Certification for U S Based Wearable ECG Recorder Means Extended Monitoring Capabilities in Europe

New Certification for U S Based Wearable ECG Recorder Means Extended Monitoring Capabilities in Europe
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LIVFRESH Becomes the World s First European Union CE Mark Certified Toothpaste for Prevention & Treatment of Periodontitis & Gingivitis as an adjunct to Professional Care

Hillrom s Fiscal Second Quarter Financial Results Exceed Guidance As Recovery Momentum Progresses Across Portfolio

Colorful Seal Assurance Supports EU MDR for Device Packaging

GOLD AWARD Expanding the Use of Flexible Packaging Chameleon for Tyve by Paxxus, Inc. The product was designed to address the requirements of the European Medical Device Regulations (MDR) going into effect in May of 2021 that the integrity of a package is “clearly evident to the final user.” Additionally, ISO 11607-1 further clarifies that the inspection takes place immediately prior to aseptic presentation. This presents a challenge for uncoated (or coated) Tyvek sealed to PET/PE of Ny/PE which shows minimal contrast at the seal, making it difficult to identify anything but gross seal defects. Chameleon “allows the user to readily evaluate the quality of a seal when used with uncoated Tyvek. Prior to opening, the seal shows as a darker color when viewed through the film side. Once the package has been peeled open, a vivid colored seal indicator presents on the Tyvek with a contrasting white seal indicator on the film,” says the company.

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