Acro Biomedical Co., Ltd.
TaiwanFDA applicant, unverified FDA FEI 3014982332
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Acro Biomedical Co., Ltd. makes
Acro Biomedical Co., Ltd. manufactures collagen-based scaffolds and matrices for bone grafting and tissue regeneration, including ABCcolla Bone Graft, ABCcolla Collagen ADM Scaffold, ABCcolla Collagen Matrix, and ABCcolla Bone Matrix. These products are designed to support tissue integration and structural repair in surgical applications.
The company’s portfolio includes devices classified as Class II and Unclassified (U) under FDA regulations, with submissions recorded in the FDA 510(k) registry. These products are listed for use in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
ABCcolla Bone Graft Ref K171629
Regimes: 510(k) Registry: 510(k)ABCcolla® Collagen ADM Scaffold Ref K233378
Regimes: 510(k) Registry: 510(k)ABCcolla Collagen Matrix Ref K162348
Regimes: 510(k) Registry: 510(k)ABCcolla Bone Matrix Ref K212156
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3014982332
- DUNS number
- 656183479
- Address
- 3rd Fl., No.57, Luke 2nd Rd., Luzhu Dist., Kaohsiung
Frequently asked questions
How many devices does Acro Biomedical Co., Ltd. have in the registry?
The registry currently lists 6 devices for Acro Biomedical Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acro Biomedical Co., Ltd.'s devices?
Among its 6 most recently registered devices, Acro Biomedical Co., Ltd. has devices listed in FDA 510(k) (4 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Acro Biomedical Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Acro Biomedical Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Acro Biomedical Co., Ltd. in the registry?
The most recently registered devices listed for Acro Biomedical Co., Ltd. include ABCCOLLA COLLAGEN MATRIX ACM05H0, ABCCOLLA BONE GRAFT ABG21H0, ABCcolla Bone Graft and ABCcolla® Collagen ADM Scaffold.