Data / Medical devices / Vietnam / Dongkuk Vietnam Co., Ltd.
Dongkuk Vietnam Co., Ltd.: FDA-registered device maker in Viet Tri Phu Tho, Vietnam, 2 510(k) clearances
Dongkuk Vietnam Co., Ltd. is registered with the FDA (registration 3021234378) in Viet Tri Phu Tho, Vietnam. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 27, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021234378
- Address
- No. 10, Thuy Van Industrial Zone, Viet Tri Phu Tho, Vietnam, 29000
- Owner or operator
- DONGKUK TRADING CO., LTD. (8040269)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 7, 2007
- Registered through
- 2026
- Brand names listed
- I Love, LATEX SHEATHS, casanova, caution, rubgy, maximum, eros, finger cot, latex finger cot, rose tex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom With Nonoxynol-9 | LTZ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Finger Cot | LZB | 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 |
|---|---|---|---|---|---|---|
| April 27, 2004 | K033163 | CAUTION CONDOMS | LTZ | Substantially Equivalent | Richard Van Haussen America, Inc. | accessdata.fda.gov |
| September 12, 1990 | K903073 | LATEX FINGER COTS | LZB | Substantially Equivalent | Dongkuk Trading Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Finger Cot
- All makers of Condom With Nonoxynol-9
- All makers of Device, Incontinence, Urosheath Type, Non-Sterile
Updated April 27, 2004. 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.