HomeAustraliaPOLYNOVO BIOMATERIALS PTY LIMITED

POLYNOVO BIOMATERIALS PTY LIMITED

Australia · Port Melbourne
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 0Class III 0unclassified 1
plus 3 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 3Class III 2
HKHong KongMDACS
2valid listings
Class IV 2
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 6 510(k), 0 PMA
Manufacturer names merged into this page: POLYNOVO BIOMATERIALS PTY LTD · POLYNOVO BIOMATERIALS PTY LIMITED

Company information

Country
Australia
City
Port Melbourne

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

ABN
82108176049
Registration status
Active
Legal form
Australian Private Company
Registered address
VIC, 3207

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12014 · K132936
12015 · K142879
12017 · K172140
12022 · K221686
22025 · K251567

FDA listed device types

Absorbable Synthetic Wound Dressing 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251567NovoSorb BTM2025-06-20
USK242149NovoSorb® MTX2025-03-05
USK221686NovoSorb Matrix2022-09-15

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