Sunder Biomedical Tech. Co., Ltd.
TaiwanFDA applicant, unverified FDA FEI 3003656001
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Sunder Biomedical Tech. Co., Ltd. makes
Sunder Biomedical Tech. Co., Ltd. manufactures hemodialysis blood tubing sets, arteriovenous fistula needle sets, and central venous catheter kits, including models SD-3L55F30J and SD-3L70F30J. These products are designed for use in vascular access procedures and hemodialysis treatments.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Renax A.V. Fistula Needle Sets Ref K003123
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3003656001
- DUNS number
- 657715348
- Address
- No. 16, Chung-Chen Rd., Chung-Ming Village, Pao-Chung Hsiang,, Yunlin County
Frequently asked questions
How many devices does Sunder Biomedical Tech. Co., Ltd. have in the registry?
The registry currently lists 10 devices for Sunder Biomedical Tech. Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sunder Biomedical Tech. Co., Ltd.'s devices?
Among its 10 most recently registered devices, Sunder Biomedical Tech. Co., Ltd. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sunder Biomedical Tech. Co., Ltd.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Sunder Biomedical Tech. Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sunder Biomedical Tech. Co., Ltd. in the registry?
The most recently registered devices listed for Sunder Biomedical Tech. Co., Ltd. include SUNDER SD-K01, SUNDER SD-G01, SUNDER SD-A16G and RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET.