Data / Medical devices / Vietnam / Intco Medical Technology Viet Nam Company Limited
Intco Medical Technology Viet Nam Company Limited: FDA-registered device maker in Dong Mai Ward Quang Ninh, Vietnam, 2 510(k) clearances
Intco Medical Technology Viet Nam Company Limited is registered with the FDA (registration 3016096058) in Dong Mai Ward Quang Ninh, Vietnam. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 30, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016096058
- Address
- LOT CN-03, Dong Mai Industrial Park, Dong Mai Ward Quang Ninh, Vietnam, 01000
- Owner or operator
- INTCO MEDICAL TECHNOLOGY VIET NAM COMPANY LIMITED (10061749)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 15, 2019
- Registered through
- 2026
- Brand names listed
- Electrode, Infant heel warmer (chemical heat pack), Overbed Table, PACK, HOT OR COLD, DISPOSABLE, Pack, hot or cold, reusable, Polyethylene Gowns, Examination, Polyethylene Gowns,Non-surgical, Surgical face mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive Backed Thermal Skin Patches | OMW | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Chair And Table, Medical | KMN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Manufacturer | accessdata.fda.gov |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Pack, Heat, Moist | IMA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 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 |
|---|---|---|---|---|---|---|
| March 30, 2021 | K202708 | Surgical Face Masks | FXX | Substantially Equivalent | Intco Medical(Hk) Co., Ltd. | accessdata.fda.gov |
| September 19, 2006 | K053254 | INFANT HEEL WARMER BY INTCO | MPO | Substantially Equivalent | Shanghai Intco Medical Supply Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Heat, Moist
- All makers of Mask, Surgical
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Chair And Table, Medical
- All makers of Non-Surgical Gown
- All makers of Infant Heel Warmer (Chemical Heat Pack)
Updated March 30, 2021. 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.