Data / Medical devices / Taiwan / Acro Biomedical Co., Ltd.
Acro Biomedical Co., Ltd.: FDA-registered device maker in Kaohsiung, Taiwan, 4 510(k) clearances
Acro Biomedical Co., Ltd. is registered with the FDA (registration 3014982332) in Kaohsiung, Taiwan. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014982332
- Address
- 3rd Fl., No.57, Luke 2nd Rd., Luzhu Dist., Kaohsiung, Taiwan, 82151
- Owner or operator
- ACRO Biomedical Co., Ltd. (10059025)
- Roles
- Manufacturer
- First device listed
- November 26, 2018
- Registered through
- 2026
- Brand names listed
- ABCcolla® Bone Graft, ABCcolla® Bone Matrix, ABCcolla® Collagen ADM Scaffold, ABCcolla® Collagen Matrix, ABCcolla® External Aesthetic Restoration Prosthesis, ABCcolla® Scar Care Dressing, ABCcolla® Scar Gel, ABCcolla® Scar Spray and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Elastomer, Silicone, For Scar Management | MDA | 1 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Material, External Aesthetic Restoration, No Adhesive | NOK | 1 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2024 | K233378 | ABCcolla® Collagen ADM Scaffold | KGN | Substantially Equivalent | Acro Biomedical Co., Ltd. | accessdata.fda.gov |
| October 8, 2021 | K212156 | ABCcolla Bone Matrix | MQV | Substantially Equivalent | Acro Biomedical Co., Ltd. | accessdata.fda.gov |
| February 1, 2018 | K171629 | ABCcolla Bone Graft | MQV | Substantially Equivalent | Acro Biomedical Co., Ltd. | accessdata.fda.gov |
| May 10, 2017 | K162348 | ABCcolla Collagen Matrix | KGN | Substantially Equivalent | Acro Biomedical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Material, External Aesthetic Restoration, No Adhesive
- All makers of Filler, Bone Void, Calcium Compound
Updated October 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.