Data / Medical devices / Pack, Hot Or Cold, Reusable / Taiwan
FDA-registered makers of Pack, Hot Or Cold, Reusable in Taiwan: 15 establishments
15 establishments in Taiwan are registered with the FDA to make Pack, Hot Or Cold, Reusable (product code IME). 1 has 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
- Taiwan
Makers of Pack, Hot Or Cold, Reusable in Taiwan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ten Comfort Corp. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 1 | February 12, 1993 | 0 | 0 | 0 | api.fda.gov |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CR Uno Industrial Co. Ltd | Taichung City, Taiwan, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fego Precision Industrial Co., Ltd. | Taichung City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Green Energy Nano Technology Co., Ltd | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Home Care Technology Co., Ltd. | Tainan City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horsing Enterprises Co Ltd | Taichung, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huntex Corporation | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lu Mark Enterprises, Inc. | XINWU Dist. Taoyuan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Overland Int'l Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plus Meditech Co., Ltd. Plant 2 | Tainan City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R&R Medical Corporation Ltd. | Sanchong District New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tien Jiang Enterprise Co., Ltd. | Tainan City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top Longmax Products Co., Ltd. | Taichung, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welltex Sports Co., Ltd. | Taipei City, Taiwan | Exporter to the US, Specification developer | 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.