PolyNovo
Biologisch abbaubare Hautmatrizen und medizinische Geräte zur Wundversorgung.
PolyNovo stellt in seinem Betrieb in Melbourne biologisch abbaubare Hautmatrizen und medizinische Geräte für die Wundversorgung her. Das Unternehmen beliefert Gesundheitssysteme, Labore, OEM-Partner oder regulierte Exportkunden in seinen aufgeführten Hauptmärkten.
- Type
- brand seeking distribution
- Location
- Melbourne, Australia
- Founded
- 1998
- Website
- polynovo.com
- Categories
- Medizin- & Gesundheitsbedarf
- Markets
- Australien, Vereinigte Staaten, Deutschland, Vereinigtes Königreich
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)