CarbonMini CO2 Diffuser

Catalogue number 1400, listed by Cardia Innovation AB, Sweden, under Insufflator, Laparoscopic. 10 manufacturers in China are registered for this product code.

Registry build 21.09.26
10manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (4), Guangdong (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HIF
Manufacturer City Province Registered as Device types
Guangzhou T.K Medical Instrument Co., Ltd. Guangzhou Guangdong Contract manufacturer 7
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Goals Sterilization Co., Ltd. Jiaxing Zhejiang Contract manufacturer 26
Wuxi Goals Medical Technology Co., Ltd. Yixing Jiangsu Contract manufacturer 24
Scivita Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 19
Global Medical Production Co., Ltd. Jiaxing Zhejiang Manufacturer 10
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Cixi Zhejiang Manufacturer 8
Guangdong Optomedic Technologies, Inc. Foshan Guangdong Manufacturer 7
Unimicro Medical Systems (Shenzhen) Co., Ltd. Shenzhen Guangdong Manufacturer 6
Tianjin Uwell Medical Device Manufacturing Co Ltd Tianjin Tianjin Manufacturer 3

Record

Regulatory record for CarbonMini CO2 Diffuser
Listed by Cardia Innovation AB, Sweden
FDA product code HIF
Device type Insufflator, Laparoscopic
Device class Class 2
Regulation 21 CFR 884.1730
Establishment Specification developer, Manufacturer, Exporter
510(k) K112975
Record published 2016-08-24
Record revised 2026-04-20 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Packaging Pack of 3, pack of 8

Catalogue Numbers

Catalogue numbers for CarbonMini CO2 Diffuser
Catalogue number Size Status
1400 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Comeg Medical Sopro 20
Insufflator, Laparoscopic Richard Wolf Gmbh 19
Airseal ConMed Corporation 10
Insufflator, Laparoscopic Smith & Nephew, Inc. 10
Gimmi Gimmi Gmbh 8
Insuflow Port Lexion Medical, LLC. 8
Aesculap Aesculap AG 7
Insufflator, Laparoscopic Stryker GmbH 6
EVA15 Palliare 6
Conmed ConMed Corporation 6
Pneumosure Stryker GmbH 6
Diversatek Healthcare Diversatek Healthcare Inc 6

Showing 12 of 114. All products under Insufflator, Laparoscopic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K112975 2012-06-22
K052125 2006-02-08

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