Swing-out Rotor

Centrifuge rotor adjustable angle, 4-place

Registry build 21.09.26
5manufacturers in China registered for this device type
11catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Shandong (1), Hunan (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KSO
Manufacturer City Province Registered as Device types
Jiangsu Kangjian Medical Apparatus Co., Ltd. Jiangyan Jiangsu Contract manufacturer 19
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70
Hunan Xiang YI Laboratory Instrument Development Co., Ltd. Changsha Hunan Manufacturer 7
Zenith Lab (Jiangsu) Co., Ltd. Changzhou Jiangsu Manufacturer 2

Record

Regulatory record for Swing-out rotor
Listed by Andreas Hettich Gmbh, Germany
FDA product code KSO
Device type Centrifuge, Blood-Bank For In Vitro Diagnostic Use
Device class Class 1
Regulation 21 CFR 864.9275
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-09-02
Record revised 2026-01-22 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Swing-out rotor
Catalogue number Size Status
4-place In distribution
4-place In distribution
4-place In distribution
4-place In distribution
4-place In distribution
2-place In distribution
6-place In distribution
6-place In distribution
6-place In distribution
2-place In distribution
4-place In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bucket Andreas Hettich Gmbh 62
Thermo Scientific Thermo Electron LED GmbH 50
Angle rotor Andreas Hettich Gmbh 6
Rotanta 460 RF Andreas Hettich Gmbh 2
Thermo Scientific Sorvall Lynx Thermo Electron LED GmbH 2
Drum rotor Andreas Hettich Gmbh 1
Rotanta 460 RC Andreas Hettich Gmbh 1
Rotanta 460 Andreas Hettich Gmbh 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