Data / Medical devices / Taiwan / Angeline Group Ltd.
Angeline Group Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 1 510(k) clearance
Angeline Group Ltd. is registered with the FDA (registration 3006798117) in New Taipei City, Taiwan. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 5, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006798117
- Address
- 2F., No. 9, Ln. 206 Zhonggang Rd., Xinzhuang Dist., New Taipei City, Taiwan, 242
- Owner or operator
- ANGELINE GROUP LTD. (10066447)
- Roles
- Manufacturer
- First device listed
- April 2, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gown, Examination | FME | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | 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 |
|---|---|---|---|---|---|---|
| August 5, 2011 | K110027 | SURGICAL FACE MASK; SURGICAL FACE MASK | FXX | Substantially Equivalent | Angeline Group , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Non-Surgical Gown
- All makers of Suit, Surgical
- All makers of Gown, Examination
Updated August 5, 2011. 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.