Malem
Malem Personal Continence Trainer (MO3) enuresis alarm (vibrating, green)
4manufacturers in China registered for this device type
22catalogue 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 | Malem Medical Ltd, United Kingdom |
|---|---|
| FDA product code | KPN |
| Device type | Alarm, Conditioned Response Enuresis |
| Device class | Class 2 |
| Regulation | 21 CFR 876.2040 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-31 |
| Record revised | 2019-01-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MO12 | In distribution | |
| MO5M | In distribution | |
| MO3V | In distribution | |
| MO4SM | In distribution | |
| MO3S1 | In distribution | |
| MO4SB | In distribution | |
| MO38T | In distribution | |
| MO17 | In distribution | |
| MO5B | In distribution | |
| MO4SC | In distribution | |
| MO3S2 | In distribution | |
| MO4S3 | In distribution | |
| MO4S2 | In distribution | |
| MO25 | In distribution | |
| MO15 | In distribution | |
| MO4S1 | In distribution | |
| MO6 | In distribution | |
| MO3S3 | In distribution | |
| MO38TC | In distribution | |
| MO7 | In distribution | |
| MO24 | In distribution | |
| MO48T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pjama | Pjama AB | 32 |
| Chummie | Theos Medical Systems, Inc. | 15 |
| 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.