Edge

Bronchoscope Adapter;For use with Olympus 190 bronchoscopes

Registry build 21.09.26
8manufacturers in China registered for this device type
20catalogue numbers in this listing

Who Else Makes It

Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JAK
Manufacturer City Province Registered as Device types
Philips Healthcare (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Qisda Electronics (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Siemens Shanghai, Medical Equipment Ltd. Shanghai Shanghai Contract manufacturer 10
Neusoft Medical Systems Co., Ltd. Shenyang Liaoning Manufacturer 1
Philips Health Technology (China) Co., Ltd. Shenyang Branch Shenyang Liaoning Specification developer 1

Record

Regulatory record for Edge
Listed by Covidien LP, United States
FDA product code JAK
Device type System, X-Ray, Tomography, Computed
Device class Class 2
Regulation 21 CFR 892.1750
Record published 2016-09-24
Record revised 2025-06-24 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Keep dry
Packaging Case of 10
Sizes Outer diameter 2 to 2.68 mm; length 1069.5 mm

Catalogue Numbers

Catalogue numbers for Edge
Catalogue number Size Status
SD190EWCTE-FT Length 1069.5 mm In distribution
SD300BAPK In distribution
SD302BAPK In distribution
SD180EWCTE-FT Outer Diameter 2.68 mm In distribution
SDK4000-FT Outer Diameter 2.68 mm In distribution
SD301BA In distribution
SDSEWCTE-FT Outer Diameter 2.68 mm In distribution
SD303BAPK In distribution
SDMEWCTE-FT Outer Diameter 2.68 mm In distribution
SDK4450-FT Outer Diameter 2.68 mm In distribution
SDK4190-FT Length 1069.5 mm In distribution
SD300LG Outer Diameter 2 mm In distribution
SD90EWCTE-FT Outer Diameter 2.68 mm In distribution
SD300BA In distribution
SDK4900-FT Second Outer Diameter,2.0,Millimeter; In distribution
SD302BA In distribution
SD303BA In distribution
SD45EWCTE-FT Outer Diameter 2.68 mm In distribution
SD301BAPK In distribution
SDKM-FT Second Outer Diameter,2.0,Millimeter; In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Visicoil IZI Medical Products LLC 48
Visicoil MR IZI Medical Products LLC 41
Illumisite Covidien LP 25
Imbio LDA Imbio, LLC 24
Revolution GE Hangwei Medical Systems Co., Ltd. 20
Gold Fiducial IZI Medical Products LLC 20
superDimension Covidien LP 17
Lodox Lodox Systems (PTY) Ltd. 12
Revolution GE Medical Systems, L.L.C. 12
Toshiba Scanner Canon Inc. 10
syngo.CT Dual Energy Siemens Healthcare Limited 7
Imactis® Imactis, SAS 6

Showing 12 of 495. All products under System, X-Ray, Tomography, Computed

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