Carescape

Assy Cscs V1 MP100D Desktop

Registry build 21.09.26
6manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (5), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code CBQ
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
Guangdong Biolight Meditech Co., Ltd. Zhuhai Guangdong Manufacturer 19

Record

Regulatory record for Carescape
Listed by GE Medical Systems Information Technologies, Inc., United States
FDA product code CBQ
Device type Analyzer, Gas, Enflurane, 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

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number
Storage Storage environment temperature -40 to 70 °C; Storage environment humidity 10 to 90 % RH
Distribution end date 2019-12-31

Catalogue Numbers

Catalogue numbers for Carescape
Catalogue number Size Status
Central Station v1 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Perma Pure Perma Pure, LLC 182
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Philips Medizin Systeme Böblingen GmbH 5
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) GE Healthcare Finland OY 4
Nafion Dryer Perma Pure, LLC 3
Pressure Monitoring Line with Nafion Dryer (BioMed Private Label) Maxtec, LLC 1
Advanced Patient Monitor Advanced Instrumentations, Inc. 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer