Validated ethylene oxide sterilization for medical plastic devices. Includes process validation, documentation, and full regulatory compliance for MDR and FDA requirements.
Manufactured by
RoweMed AG - Medical 4 Life
Parchim, Germany
RoweMed AG - Medical 4 Life is an innovative MedTech company. Our focus is on the development and production of medical plastic products, especially complex customized systems for the handling of sensitive drugs. We realize turnkey projects for our customers from the first sketch to CAD design and rapid prototyping to the approved serial product. For our projects we offer full documentation according to the Medical Device Directive 93/42/EEC. In our certified clean rooms (ISO 7) we offer injection molding, assembly and packaging from one source. Thus, we realize single-item production, small series and automated large series with high efficiency.
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TEKNOMAR MAK.İML.İTH.İHR.SAN.TİC.LTD.ŞTİ.
Türkiye · 1 relevant product
Dongguan City Yixin Sterilization Technology Service Co., Ltd
China · 3 relevant products
Industrias Plasticas Medicas, S.A. de C.V.
Mexico · 1 relevant product
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TEKNOMAR MAK.İML.İTH.İHR.SAN.TİC.LTD.ŞTİ. · Türkiye
Professional sterilization service utilizing ethylene oxide gas technology for medical devices and equipment. Includes processing, validation, and documentation of sterilization cycles.
Dongguan City Yixin Sterilization Technology Service Co., Ltd · China
Professional sterilization services using ethylene oxide gas for medical devices, instruments, and consumables. The facility operates under ISO 11135 and ISO 13485 standards with validated processes and documentation.
Industrias Plasticas Medicas, S.A. de C.V. · Mexico
Validated chamber sterilization services using ethylene oxide for medical devices. Ensures compliance with international sterilization standards for single-use and reusable medical equipment.
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