Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.
TaiwanFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. makes
Medicom Asia-Pacific Holdings Ltd. Taiwan Branch manufactures sterilization pouches and reels, designed for use in medical sterilization processes to protect devices and instruments during autoclaving or ethylene oxide sterilization.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway in the United States. The company operates with a Taiwan-based branch while maintaining regulatory compliance in the US market.
Catalogue
Medicom Sterilization Pouch and Reel Ref K243431
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Medicom Asia-Pacific Holdings Limited. Taiwan Branch Wujie Township Yilan · TW FEI 3008132392
Frequently asked questions
How many devices does Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. have in the registry?
The registry currently lists 1 device for Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.'s devices?
Among its 1 most recently registered device, Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. has devices listed in FDA 510(k) (1 device).
What risk classes do Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. in the registry?
The most recently registered devices listed for Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. include Medicom Sterilization Pouch and Reel.
Which FDA establishments are linked to Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.?
1 FDA establishment is linked to Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. in the registry; they are listed on the company page.