Aptar Pharma gains CE marking for LuerVax and Spray Divider
- Aptar Pharma’s LuerVax and accompanying Spray Divider received CE marking under the EU Medical Device Regulation.
- LuerVax is an intranasal delivery device intended for use by healthcare professionals when connected to a compatible LuerLock syringe.
- The Spray Divider enables two sequential sprays—one per nostril—and is available in 200 µL and 500 µL sizes.
- Aptar offers drug‑delivery, vaccine technology, regulatory support, industrialization and manufacturing to support programs from early clinical studies through commercialization; LuerVax is a Class I non‑sterile single‑use device under MDR.
CE marking and purpose
LuerVax and its optional Spray Divider have been CE marked under the EU Medical Device Regulation, confirming they meet European safety and performance requirements for medical devices. The platform is positioned to support customers developing intranasal vaccine products.
Product details
LuerVax is an intranasal delivery device intended for administration by a healthcare professional when connected to a compatible LuerLock syringe. The Spray Divider is designed to deliver the prepared syringe volume as two sequential sprays, one per nostril, and is offered in 200 µL and 500 µL sizes.
Support for development
The CE‑marked platform is intended to support development activities from early clinical studies through commercialization. Customers can leverage Aptar Pharma’s capabilities in drug delivery, vaccine technologies, regulatory support, industrialization and manufacturing as a single integrated partner.
Regulatory status
LuerVax is classified as a Class I non‑sterile, single‑use medical device under the MDR and is validated with compatible LuerLock syringes. The Spray Divider is an optional component intended for use with LuerVax and the corresponding LuerLock syringe; users should refer to the Instructions for Use for full intended use, warnings and precautions.
Source: Aptar