Veloxion

Veloxion Fluid Control Set

Registry build 21.09.26
1manufacturer
6catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FJL
Manufacturer City Province Registered as Device types
Peter’s Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9

Record

Regulatory record for Veloxion
Listed by Aulea Medical, Inc., United States
FDA product code FJL
Device type Resectoscope
Device class Class 2
Regulation 21 CFR 876.1500
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K230205
Record published 2025-01-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date, serial number
Packaging Pack of 3

Catalogue Numbers

Catalogue numbers for Veloxion
Catalogue number Size Status
1878 In distribution
1877 In distribution
2516 In distribution
2490 In distribution
1327 In distribution
3199 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Olympus Olympus Winter & IBE Gmbh 58
E-Line Richard Wolf Gmbh 33
Ureterorenoscope Sopro-Comeg GmbH 28
AED National Advanced Endoscopy Devices, Inc. 24
Shark Richard Wolf Gmbh 21
Urology syringe Sopro-Comeg GmbH 15
Resectoscope Richard Wolf Gmbh 14
Resectoscope Karl Storz GmbH & Co. KG 11
Panoview Richard Wolf Gmbh 8
Urology Evacuator Sopro-Comeg GmbH 7
Piranha Richard Wolf Gmbh 6
Gimmi Gimmi Gmbh 5

Showing 12 of 18. All products under Resectoscope

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