AVITA Medical
细胞喷雾皮肤修复和伤口护理产品。
AVITA Medical 在其墨尔本工厂生产细胞喷雾皮肤修复和伤口护理产品。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
- 1993
- Website
- avita-medical.com
- Categories
- 医疗保健用品
- Markets
- 澳大利亚, 美国, 英国, 德国
Verified facts
- lei-lapsed (amber), checked 2026-08-07 GLEIF global LEI register (golden copy)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- FDA Registered FDA Establishment Registration
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)