Sky Medical
Sky Medical is a contract manufacturer of medical devices with over 20 years of experience in the medical device manufacturing and distribution market. Located in the Slovak Republic, it offers full-scale services including product development, manufacturing, assembly, packaging, sterilization, storage, and logistics. The company is committed to high quality standards, regulatory compliance, and providing cost-effective solutions to its OEM partners across Europe.
Industries
Nr. of Employees
small (1-50)
Sky Medical
Samorin, Bratislava, Slovakia (Slovak Republic), Europe
Patents
Products
Physiology pressure transducer sets
Pre-assembled invasive blood pressure monitoring sets with integrated transducer, flush device and 3-way stopcock; available in single to multi-channel configurations with color coding and needle-free access.
Total parenteral nutrition (TPN) sets
Multi-access infusion and nutrition lines designed for neonatal and clinical drug delivery with low priming volumes, UV-photosensitive tubing options, filters and needle-free/check valve options.
Contrast media delivery sets
High-pressure injection lines, manifolds and pre-assembled sets for interventional radiology and cardiology, including monitoring lines and contrast saver options for CT and MRI procedures.
Fluid transfer, connecting lines and administration sets
Infusion and oncology preparation systems, mixing and IV administration sets with needle-free valves, IV filters and customizable configurations for pharmacy and clinical use.
Physiology pressure transducer sets
Pre-assembled invasive blood pressure monitoring sets with integrated transducer, flush device and 3-way stopcock; available in single to multi-channel configurations with color coding and needle-free access.
Total parenteral nutrition (TPN) sets
Multi-access infusion and nutrition lines designed for neonatal and clinical drug delivery with low priming volumes, UV-photosensitive tubing options, filters and needle-free/check valve options.
Contrast media delivery sets
High-pressure injection lines, manifolds and pre-assembled sets for interventional radiology and cardiology, including monitoring lines and contrast saver options for CT and MRI procedures.
Fluid transfer, connecting lines and administration sets
Infusion and oncology preparation systems, mixing and IV administration sets with needle-free valves, IV filters and customizable configurations for pharmacy and clinical use.
Services
Full production services for single-use devices to complex integrated devices, including process development, assembly, testing and scale-up in validated cleanrooms.
Turnkey legal manufacturing with CE Marking technical file creation, UDI and labeling support, regulatory submissions and MDR transition assistance.
Manufacture and supply of CE-marked disposable medical products under a partner’s brand while retaining legal manufacturer responsibilities as agreed.
Consultancy for EN ISO 13485:2021 QMS implementation, cleanroom planning/validation, supplier quality and operational validation activities.
Kit assembly and packaging within controlled cleanroom environments with full traceability, warehousing, inventory management and logistics services.
Full production services for single-use devices to complex integrated devices, including process development, assembly, testing and scale-up in validated cleanrooms.
Turnkey legal manufacturing with CE Marking technical file creation, UDI and labeling support, regulatory submissions and MDR transition assistance.
Manufacture and supply of CE-marked disposable medical products under a partner’s brand while retaining legal manufacturer responsibilities as agreed.
Consultancy for EN ISO 13485:2021 QMS implementation, cleanroom planning/validation, supplier quality and operational validation activities.
Kit assembly and packaging within controlled cleanroom environments with full traceability, warehousing, inventory management and logistics services.
Expertise Areas
- Contract manufacturing of medical devices
- Medical device assembly and kit packaging
- Catheter and complex tubing set production
- Regulatory compliance and CE marking (MDR)
Key Technologies
- ISO Class 7 cleanrooms
- ISO Class 8 cleanrooms
- Thermoforming packaging
- Tubing assembly and bonding