Data / Medical devices / Cambodia / Medtecs (cambodia) Corp. Limited
Medtecs (cambodia) Corp. Limited: FDA-registered device maker in Srok Kampong Siem Kampong Cham, Cambodia, 1 510(k) clearance
Medtecs (cambodia) Corp. Limited is registered with the FDA (registration 3012344767) in Srok Kampong Siem Kampong Cham, Cambodia. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012344767
- Address
- National road number 7, Phum Ampil Leu, Khum Ampil, Srok Kampong Siem Kampong Cham, Cambodia, 030501
- Owner or operator
- MEDTECS (CAMBODIA) CORP. LIMITED (10074525)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- May 26, 2020
- Registered through
- 2026
- Brand names listed
- AMD-Ritmed AssureWear Versagown, ASTM PB70 Level 4 Isolation Gown, Bouffant Cap, Chemo Gown, Conductive Shoe and Shoe Cover, Coverall with tape, Disposable Coverall, Disposable Isolation Gown and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Component, Cast | LGF | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Contract manufacturer, Foreign private label distributor | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Contract manufacturer | accessdata.fda.gov |
| Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs | QSO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 21, 2022 | K210414 | CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown | FYC | Substantially Equivalent | Medtecs (Taiwan) Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Examination
- All makers of Gown, Isolation, Surgical
- All makers of Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
- All makers of Cap, Surgical
- All makers of Dress, Surgical
- All makers of Non-Surgical Gown
Updated October 21, 2022. 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.