Comen
Catalogue number C50, listed by Shenzhen Comen Medical Instruments Co., Ltd., China, under Alarm, Blood-Pressure. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Philips Goldway (Shenzhen) Industrial Inc. | Shenzhen | Guangdong | Specification developer | 7 |
Record
| Listed by | Shenzhen Comen Medical Instruments Co., Ltd., China |
|---|---|
| FDA product code | DSJ |
| Device type | Alarm, Blood-Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1100 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K191106 |
| Record published | 2020-02-27 |
| Record revised | 2026-04-16 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 5 |
| Alarm, Blood-Pressure | GE Healthcare Finland OY | 1 |
| EEG Module | Philips Medizin Systeme Böblingen GmbH | 1 |
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.