HomeNew ZealandAroa Biosurgery , Ltd.

Aroa Biosurgery , Ltd.

New Zealand · Airport Oaks
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 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
6listed device types
Class I 0Class II 4Class III 0unclassified 2
plus 14 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class III 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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 States14 registration records, 13 510(k), 0 PMA
Manufacturer names merged into this page: Aroa Biosurgery Ltd · AROA BIOSURGERY LTD. · AROA BIOSURGERY LTD

Company information

Country
New Zealand
City
Airport Oaks

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.

FDA 510(k) clearances by year

32016
22017
12018
12019
12020
12021
12023
12024
12025
12026

FDA listed device types

Mesh, Surgical, Polymeric 1Bone Grafting Material, Animal Source 1Barrier, Animal Source, Intraoral 1Mesh, Surgical 1Dressing, Wound, Drug 1Wound Dressing With Animal-Derived Material(S) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260669Endoform Dermal Template2026-06-24
USK250598Endoform Reconstructive Template - PLGA2025-06-03
USK231305Endoform Dental Membrane2024-01-23

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