Data / Medical devices / Taiwan / Advanced Medical Design Co., Ltd.
Advanced Medical Design Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 2 510(k) clearances
Advanced Medical Design Co., Ltd. is registered with the FDA (registration 3010437008) in New Taipei City, Taiwan. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 30, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010437008
- Address
- 4F-5F, No29, Wuquan 5th Rd. Wugu Dist., New Taipei City, Taiwan, 248
- Owner or operator
- Advanced Medical Design CO., LTD. (10044957)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- September 4, 2013
- Registered through
- 2026
- Brand names listed
- Lap Bag with Fabric Pouch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Contract manufacturer | accessdata.fda.gov |
| Anti Fog Solution And Accessories, Endoscopy | OCT | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Contract manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Contract manufacturer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 30, 2021 | K210248 | Lab Bag with Fabric Pouch | GCJ | Substantially Equivalent | Advanced Medical Design Co., Ltd. | accessdata.fda.gov |
| January 22, 2019 | K181887 | AMD Anti-Fog Solution | OCT | Substantially Equivalent | Advanced Medical Design Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Insufflator, Laparoscopic
- All makers of Laparoscopic Accessories, Gynecologic
- All makers of Tubing/Tubing With Filter, Insufflation, Laparoscopic
- All makers of Anti Fog Solution And Accessories, Endoscopy
- All makers of Instrument, Manual, Surgical, General Use
Updated July 30, 2021. 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.