Medical Device Manufacturer · TW , Taipei City

Medtecs (Taiwan) Corp.

2 submissions · 2 cleared · Since 2022

Total

Cleared

Denied

Medtecs (Taiwan) Corp. — FDA 510(k) Submissions

Medtecs (Taiwan) Corp. has submitted 2 FDA 510(k) premarket notifications since 2022, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mask, Surgical, Gown, Isolation, Surgical . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown

K210414 · FYC Gown, Isolation, Surgical · General Hospital

Oct 2022 617d

ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G

K203376 · FXX Mask, Surgical · General Hospital

Mar 2022 470d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Medtecs (Taiwan) Corp.

Medtecs (Taiwan) Corp. — FDA 510(k) Submissions

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