Data / Medical devices / Taiwan / Modern Healthcare Corp.
Modern Healthcare Corp.: FDA-registered device maker in TIEN CHUNG COUNTY, CHANG-HWA Changhua, Taiwan, 3 510(k) clearances
Modern Healthcare Corp. is registered with the FDA (registration 8022899) in TIEN CHUNG COUNTY, CHANG-HWA Changhua, Taiwan. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 26, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 8022899
- FEI number
- 3004621557
- Address
- No. 751, Chung Chou RD., Sec.2, TIEN CHUNG COUNTY, CHANG-HWA Changhua, Taiwan, 52045
- Owner or operator
- MODERN HEALTHCARE CORP. (8022899)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 22, 2001
- Registered through
- 2026
- Brand names listed
- Absorbent Medical Fiber, Adhesive Tape and Andage, Eye Pad, FORA Medical Mask, Face Mask (Except N95 Respirator), Modern Healthcare, Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop, Nonresorbable Gauze and Sponge and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US, 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 26, 2020 | K201549 | Motex Anti-Fog Surgical Face Mask | FXX | Substantially Equivalent | Modern Healthcare Corp. | accessdata.fda.gov |
| December 18, 2019 | K191898 | Sterile Latex Powder-Free Surgical Gloves | KGO | Substantially Equivalent | Modern Healthcare Corp. | accessdata.fda.gov |
| March 21, 2007 | K063043 | SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP | FXX | Substantially Equivalent | Modern Healthcare Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Fiber, Medical, Absorbent
- All makers of Mask, Surgical
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Pad, Eye
- All makers of Surgeon'S Gloves
Updated August 26, 2020. 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.