Shinva Medical Instrument Co., Ltd.
Pembuat peralatan sterilisasi dan desinfeksi rumah sakit terkemuka di Tiongkok, juga memproduksi sistem radioterapi.
Shinva Medical memproduksi alat sterilisasi uap, alat sterilisasi plasma, mesin cuci dan disinfektan tingkat farmasi, akselerator linier terapi radiasi, dan peralatan brakiterapi. Perusahaan milik negara dan bersertifikat ISO 13485 ini melengkapi departemen pasokan steril pusat (CSSD) di seluruh rumah sakit di Tiongkok dan Asia dan telah bermitra dengan Elekta untuk distribusi radioterapi.
- Type
- Manufacturer
- Location
- Zibo, China
- Founded
- 1943
- Website
- shinva.com
- Categories
- Perlengkapan Medis & Kesehatan, Mesin Industri
- Markets
- Tiongkok, India, Filipina, Vietnam, Thailand
Verified facts
- 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
- web-presence-since (green), checked 2026-08-09 Internet Archive (Wayback)
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
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)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission