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Aroa Biosurgery

Active in EUDAMED

Registered as Aroa Biosurgery Ltd. (Aroa) in EUDAMED

Also registered as AROA BIOSURGERY LIMITED

New Zealandfrom SRN EUDAMED SRN NZ-MF-000003726

Part of Aroa Biosurgery Ltd.

Devices
269
Registrations
EUDAMED
FDA recalls
24

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA recalls

What Aroa Biosurgery makes

Aroa Biosurgery manufactures animal-derived wound matrix dressings, including collagen-based bioscaffolds for soft tissue repair, and bioabsorbable surgical meshes for extra-gynaecological applications. Their products include non-antimicrobial and antimicrobial versions of collagen-based meshes, as well as composite bioscaffolds designed for tissue regeneration. The company also produces devices for tissue morcellation, such as the Myriad Morcells™ system, and dermal templates for wound healing.

The company’s devices are classified under FDA categories Class II and Unclassified (U), with regulatory submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These products are listed under U.S. regulatory frameworks, reflecting compliance with FDA requirements for medical devices. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue269

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Company details

EUDAMED record synced 7 Nov 2026

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(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 20 Feb 2031

EUDAMED certificates (1)

DEKRA Certification B.V. 0344 1 certificate

  • 3829441CE01 Active Supplemented

    Quality management system EU MDR

    Issued
    26 May 2026
    Expires
    20 Feb 2031
    Reason
    Add device or group

FDA recalls24

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 24 recalls initiated by Aroa Biosurgery, the earliest on 2018-04-06 and the most recent on 2018-11-27. By recorded status: 24 terminated. The reasons filed fall into these groups: packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 24
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

Showing the 10 most recent of 24 recalls.

  • 2018

    • 27 Nov 2018 Z-0377-2019 Class II Terminated Potential for pouch seal failure Distribution: US Nationwide Distribution Submission number: K092096
    • 27 Nov 2018 Z-0378-2019 Class II Terminated Potential for pouch seal failure Distribution: US Nationwide Distribution Submission number: K092096
    • 27 Nov 2018 Z-0379-2019 Class II Terminated Potential for pouch seal failure Distribution: US Nationwide Distribution Submission number: K092096
    • 6 Apr 2018 Z-0415-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0416-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0417-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0418-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0419-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0420-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0421-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
Show all 24 recalls

  • 2018

    • 6 Apr 2018 Z-0422-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0423-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0424-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0425-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0426-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0427-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0428-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0429-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0430-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0431-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0432-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0433-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0434-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633
    • 6 Apr 2018 Z-0435-2019 Class II Terminated Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. Submission number: K153633

Frequently asked questions

How many devices does Aroa Biosurgery have in the registry?

The registry currently lists 269 devices for Aroa Biosurgery. Devices recorded under merged duplicate company entries are counted once.

Which registries list Aroa Biosurgery's devices?

Among its 50 most recently registered devices, Aroa Biosurgery has devices listed in FDA GUDID (50 devices).

What risk classes do Aroa Biosurgery's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Aroa Biosurgery's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Aroa Biosurgery?

FDA recall records list 24 recalls initiated by Aroa Biosurgery, the most recent initiated on 27 Nov 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Aroa Biosurgery?

EUDAMED lists 1 certificate for Aroa Biosurgery (quality management system) under MDR. The most recent was issued on 26 May 2026.

What are the newest devices from Aroa Biosurgery in the registry?

The most recently registered devices listed for Aroa Biosurgery include Symphony OPX™ Proliferative Bioscaffold SY02HA003H, Symphony™ Proliferative Bioscaffold CM03HA003R, Symphony OPX™ Proliferative Bioscaffold SY02HA004H and Symphony OPX™ Proliferative Bioscaffold SY02HA006L.

Generated automatically from registry data and not verified by a human reviewer.