Chummie
15 catalogue numbers from TCE25O, listed by Theos Medical Systems, Inc., United States, under Alarm, Conditioned Response Enuresis. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Shantou City KIN Seng Plastic Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Foshan RM Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 1 |
| Rosti Integrated Manufacturing Solutions (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
Record
| Listed by | Theos Medical Systems, Inc., United States |
|---|---|
| FDA product code | KPN |
| Device type | Alarm, Conditioned Response Enuresis |
| Device class | Class 2 |
| Regulation | 21 CFR 876.2040 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-01-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TCE25O | In distribution | |
| TCE25P | In distribution | |
| TC300B | In distribution | |
| TCI300 | In distribution | |
| TCE25G | In distribution | |
| TCE25P | In distribution | |
| TCE25G | In distribution | |
| TC310B | In distribution | |
| TCE25O | In distribution | |
| TC300P | In distribution | |
| TCE25B | In distribution | |
| TC310P | In distribution | |
| TC310G | In distribution | |
| TCE25B | In distribution | |
| TC300G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pjama | Pjama AB | 32 |
| Malem | Malem Medical Ltd | 22 |
| Tena | Essity Hygiene and Health AB | 11 |
| WatchCare | Hill-ROM, Inc. | 4 |
| Shield | Theos Medical Systems, Inc. | 4 |
| SIM™ tablet accessories | Simavita (Aust) PTY Ltd | 4 |
| SIM™ kit | Simavita (Aust) PTY Ltd | 4 |
| SIM pod kit | Simavita (Aust) PTY Ltd | 4 |
| DryEasy | Marvelworks Ltd. | 2 |
| Kateway | Kateway Limited | 2 |
| Fitright | Medline Industries, Inc. | 2 |
| Smart | Theos Medical Systems, Inc. | 2 |
Showing 12 of 49. All products under Alarm, Conditioned Response Enuresis
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.