PolyNovo
可生物降解的真皮基质和伤口护理医疗设备。
PolyNovo 在其墨尔本工厂生产可生物降解的真皮基质和伤口护理医疗设备。该公司在其上市主要市场上为医疗保健系统、实验室、OEM 合作伙伴或受监管的出口客户提供服务。
- Type
- Manufacturer
- Location
- Melbourne, Australia
- Founded
- 1998
- Website
- polynovo.com
- Categories
- 医疗保健用品
- Markets
- 澳大利亚, 美国, 德国, 英国
Verified facts
- lei-lapsed (amber), checked 2026-08-07 GLEIF global LEI register (golden copy)
- fda-registered (green), checked 2026-08-09 FDA
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- domain-registered (green), checked 2026-08-09 Domain registry record
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)