Data / Medical devices / Pack, Hot Or Cold, Reusable / Vietnam
FDA-registered makers of Pack, Hot Or Cold, Reusable in Vietnam: 15 establishments
15 establishments in Vietnam are registered with the FDA to make Pack, Hot Or Cold, Reusable (product code IME). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Pack, Hot Or Cold, Reusable
- Product code
- IME
- Country
- Vietnam
Makers of Pack, Hot Or Cold, Reusable in Vietnam
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acode Sporting Goods Company Limited | Ho Chi Minh, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Actlife Technology Co., Ltd - Thanh Hoa Branch | Trung Chinh Commune Thanh Hoa, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch In Phu Tho, Thygesen Textile Vietnam Company Limited | Yen Lap Commune Phu Tho, Vietnam | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| CONG TY TNHH Wellbeing Technology Co., Ltd. | TP. Hai Phong, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foundation Wellness International Co., LTD (FWIL) | Binh Duong, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hameco Hy Co., Ltd | Hung Yen Province, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intco Medical Technology Viet Nam Company Limited | Dong Mai Ward Quang Ninh, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koolcare Medical Equipment (vietnam) Company Limited | Ho Chi Minh City, Vietnam | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liang Cheng Sporting Goods Company Limited | Ben Cat Ward Ho Chi Minh, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ogawa Wellness Vietnam Company Limited | Long An, Vietnam | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Praegear Viet Nam Co., Ltd. | Duc Hoa District Long An, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reak Vietnam Company Limited | Nhon Trach Commune Dong Nai, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rapid Aid Vietnam Co., Ltd | An Quang Commune Hai Phong, Vietnam | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top-Tek Technology (vietnam) Company Limited | Thu Dau Mot Binh Duong, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vietnam Heidacare Appliance Co., Ltd | Bac Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.