PolyNovo
Matrices dérmicas biodegradables y dispositivos médicos para el cuidado de heridas.
PolyNovo fabrica matrices dérmicas biodegradables y dispositivos médicos para el cuidado de heridas en sus operaciones de Melbourne. La empresa suministra sistemas de atención médica, laboratorios, socios OEM o clientes de exportación regulados en sus mercados primarios listados.
- Type
- brand seeking distribution
- Location
- Melbourne, Australia
- Founded
- 1998
- Website
- polynovo.com
- Categories
- Suministros médicos y sanitarios
- Markets
- Australia, Estados Unidos, Alemania, Reino Unido
Verified facts
- 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
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- lei-lapsed (amber), checked 2026-08-30 GLEIF global LEI register (golden copy)
- 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)
- 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)