Aplan Well Enterprise Co., Ltd.
TaiwanFDA applicant, unverified
- Devices
- 1
What Aplan Well Enterprise Co., Ltd. makes
Aplan Well Enterprise Co., Ltd. manufactures the APLAN A.V. FISTULA NEEDLE SET, a device designed for creating vascular access by forming arteriovenous fistulas.
The company’s products are regulated as Class II devices under the FDA’s 510(k) clearance pathway and are listed in the FDA registry. The manufacturer is based in the United States.
Catalogue
Aplan A.V. Fistula Needle Set Ref K112734
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aplan Well Enterprise Co., Ltd. have in the registry?
The registry currently lists 1 device for Aplan Well Enterprise Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aplan Well Enterprise Co., Ltd.'s devices?
Among its 1 most recently registered device, Aplan Well Enterprise Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Aplan Well Enterprise Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Aplan Well Enterprise Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aplan Well Enterprise Co., Ltd. in the registry?
The most recently registered devices listed for Aplan Well Enterprise Co., Ltd. include APLAN A.V. FISTULA NEEDLE SET.