Shinva Medical Instrument Co., Ltd.
China's leading hospital sterilisation and disinfection equipment maker, also producing radiotherapy systems.
Shinva Medical manufactures steam sterilisers, plasma sterilisers, pharmaceutical-grade washers and disinfectors, radiation therapy linear accelerators, and brachytherapy equipment. State-owned and ISO 13485 certified, the company equips central sterile supply departments (CSSD) across Chinese and Asian hospitals and has partnered with Elekta for radiotherapy distribution.
- Type
- Manufacturer
- Location
- Zibo, China
- Founded
- 1943
- Website
- shinva.com
- Categories
- Medical & Healthcare Supplies, Industrial Machinery
- Markets
- China, India, Philippines, Vietnam, Thailand
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- web-presence-since (green), checked 2026-08-09 Internet Archive (Wayback)
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- domain-registered (green), checked 2026-08-09 Domain registry record
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- lei-lapsed (amber), checked 2026-08-09 GLEIF
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- Good Manufacturing Practice
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)