Aroa Biosurgery Ltd.
Active in EUDAMEDNew Zealandfrom SRN EUDAMED FDA SRN NZ-MF-000003726
Aroa Biosurgery Ltd. is a medical device manufacturer based in New Zealand, with 10 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II and Unclassified; EU Class III) as of 13 Nov 2026.
- Devices
- 10
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 8
- EUDAMED 2
- FDA GUDID 2
- Device classes
- FDA Class II 5
- FDA Unclassified 3
- EU Class III 2
- Top EMDN categories
- Sites and related companies
- S4M Europe authorised representative
- Identifiers
- EUDAMED SRN NZ-MF-000003726
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
- Authorised rep.
- S4M EuropeFR
Catalogue
Endoform Dermal Template Ref K260669
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDD Registry: EUDAMEDGUDID
Endoform Reconstructive Template - PLGA Ref K250598
Regimes: 510(k) Registry: 510(k)Myriad Particles Ref K200502
Regimes: 510(k) Registry: 510(k)Symphony Ref K200413
Regimes: 510(k) Registry: 510(k)Endoform Dental Membrane Ref K231305
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Enivo™ Ref K223373
Regimes: 510(k) Registry: 510(k)Endoform Restella Ref K183398
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDD Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- NZ-MF-000003726
- EUDAMED status
- Active
- EUDAMED registered name
- Aroa Biosurgery Ltd.
- EUDAMED abbreviated name
- Aroa
- Registered address
- 2, Kingsford Smith Place, 2022, Airport Oaks, Auckland, New Zealand
- Website
- www.aroa.com
- Phone
- +64 9 869 3035
- PRRC contact
- Enoch Mok
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 20 Feb 2031
DEKRA Certification B.V. 0344 1 certificate
- 3829441CE01 Active
Quality management system EU MDR
- Issued
- 26 May 2026
- Expires
- 20 Feb 2031
- Reason
- Add device or group
FDA establishments
- Aroa Biosurgery NZ
From the company website
Aroa Biosurgery is committed to offering products for soft tissue repair and managing wounds with AROA ECM™ platform technology.
Frequently asked questions
How many devices does Aroa Biosurgery Ltd. have in the registry?
The registry currently lists 10 devices for Aroa Biosurgery Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aroa Biosurgery Ltd.'s devices?
Among its 10 most recently registered devices, Aroa Biosurgery Ltd. has devices listed in EUDAMED (2 devices), FDA 510(k) (8 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Aroa Biosurgery Ltd.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Aroa Biosurgery Ltd.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Aroa Biosurgery Ltd.?
EUDAMED lists 1 certificate for Aroa Biosurgery Ltd. (quality management system) under MDR. The most recent was issued on 26 May 2026.
What are the newest devices from Aroa Biosurgery Ltd. in the registry?
The most recently registered devices listed for Aroa Biosurgery Ltd. include Endoform Dermal Template, F10248-1012P, Endoform Reconstructive Template - PLGA and Myriad Particles.
Which FDA establishments are linked to Aroa Biosurgery Ltd.?
1 FDA establishment is linked to Aroa Biosurgery Ltd. in the registry; they are listed on the company page.