Carescape
Carescape Central Station V1 Upgrade KIT From CIC V5 ON MP100
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (4), 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 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | NHP |
| Device type | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1500 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-06-24 |
| Record revised | 2025-04-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2019-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Central Station v1 upgrade | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | GE Medical Systems Information Technologies, Inc. | 2 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | GE Healthcare Finland OY | 2 |
| Carescape B650 | GE Healthcare Finland OY | 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.