Data / Medical devices / Taiwan / Medicom Asia-Pacific Holdings Limited. Taiwan Branch
Medicom Asia-Pacific Holdings Limited. Taiwan Branch: FDA-registered device maker in Wujie Township Yilan, Taiwan, 1 510(k) clearance
Medicom Asia-Pacific Holdings Limited. Taiwan Branch is registered with the FDA (registration 3008132392) in Wujie Township Yilan, Taiwan. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 21, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3008132392
- Address
- No.11, Sec2, Ligong 1st Rd, Wujie Township Yilan, Taiwan, 26841
- Owner or operator
- Medicom Group (9007111)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- May 1, 1996
- Registered through
- 2027
- Brand names listed
- Medicom AssureMask, Medicom SafeBasics, Medicom SafeMask, Medicom Sterilization Pouches & Reels, Pouches & Reels
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Contract manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| February 21, 2025 | K243431 | Medicom Sterilization Pouch and Reel | FRG | Substantially Equivalent | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Wrap, Sterilization
Updated February 21, 2025. 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.