Skyler Medical Manufacturing Sdn. Bhd. | ORIZI Group

About

Skyler Medical Manufacturing Sdn. Bhd. (operating name Skyler) is a Malaysian manufacturer of solution-based medical products and a member company of ORIZI Group. It produces ultrasound gel, ECG gel, defibrillation gel and lubricant gel in sterile and non-sterile formats, plus a general disinfectant, at its facility in Lahat, Perak. Its water-based formulations are described as hypoallergenic, non-staining and long-lasting on patients, and non-corrosive to medical equipment. Services: medical solution R&D development, OEM and ODM services, packaging re-engineering and sterile packaging. The company's stated approach is a holistic contamination-control strategy that reduces bioburden. Company registration: Skyler Medical Manufacturing Sdn. Bhd., registration no. 202101038874 (1439174-P). Role in ORIZI Group: medical device manufacturing. Quality systems and licences listed by the company and ORIZI Group: ISO 13485:2016 medical device quality management (assessed by KGS Certification Sdn. Bhd., cert. 510512); Medical Device Authority (MDA) establishment licence MDA-7783-K125; ISO Class 8 clean room; JAKIM Halal; and Pioneer Status. The company also lists ISO 10993 (biological evaluation of medical devices) and ISO 14971 (risk management for medical devices) among the standards it works to. Facility: Plant A on 4,000 sq ft plus 7,000 sq ft of land with a dedicated control room, and Plant 2 on 5,931 sq ft with an ISO 8 clean room, both operated to ISO 13485:2016. Source: the company's own website and the ORIZI Group website (orizigroup.com: Our Companies, Our Certifications and Our Facilities pages), captured 26 September 2026. These are company-stated details; ask the manufacturer for certificate copies and confirm them with the issuing bodies before ordering.