Manufacturer registered with FDA
Shummi Enterprise Co, Ltd
Taipei 105, Taiwan. Lists 9 dental device types with FDA across 2 registered establishments.
- Device types listed
- 9
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 273 registrations outside the US
- Establishments
- 2China, Taiwan
Registered in 2 markets
Where regulators' registries name Shummi Enterprise Co, Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shummi Enterprise Co, Ltd | 9 device types | — | Below |
| Colombia | INVIMA | Manufacturer | SHUMEI INDUSTRIAL (HEBEI) CO., LTDA.SHUMEI INDUSTRIAL (HEBEI) CO., LTD · SHUMEI INDUSTRIAL (HEBEI) CO., LTD. | 73 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Shummi Enterprise Co, Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MOUTH DENTAL | 2007 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | MANUAL TOOTHBRUSHPre-pasted toothbrush | 2007 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | DENTAL WAX | 2007 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | Explorer | 2011 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | POWERED DENTAL | 2007 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental Floss | 2007 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Comfort Picks | 2017 |
| Tongue ScraperLCN · Class 1 | — | Maker | ENFRESH ORIGINAL TONGUE BRUSHMetal Tongue Scraper | 2007 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | Super Dental Kit | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHUMEI INDUSTRIAL (HEBEI) CO., LTD.FDA reg. 3006536571 | Cangzhou Hebei, China | Contract manufacturer, Foreign exporter, Manufacturer |
| Shummi Enterprise Co., Ltd.FDA reg. 3005816808 | Taipei, Taiwan | Contract manufacturer, Foreign exporter, Manufacturer |
Other names on FDA records
Shumei Industrial (Hebei) Co., Ltda.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9007361). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.