Cyclone Bone Marrow Concentration System 120ml

Catalogue number CYC-120-01, listed by EmCyte Corporation, United States, under Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use. 37 manufacturers in China are registered for this product code.

Registry build 21.09.26
37manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (9), Zhejiang (7), Guangdong (6). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JQC
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Guangzhou Four E’s Scientific Co., Ltd. Guangzhou Guangdong Contract manufacturer 61
Jiangsu Kangjian Medical Apparatus Co., Ltd. Jiangyan Jiangsu Contract manufacturer 19
Shanghai Gene Era Bio-Science Co., Ltd. Fengxian Shanghai Contract manufacturer 8
Dongguan Q & S Electronic Manufacturing Company Limited Dongguan Guangdong Contract manufacturer 5
Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. Suzhou Jiangsu Contract manufacturer 1
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Zhejiang Lidesen Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 100
Anji Spenq Industrial Co., Ltd. Huzhou Zhejiang Manufacturer 85
Ningbo Greetmed Medical Instruments Co., Ltd. Ningbo Zhejiang Specification developer 75
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70

Showing 12 of 37. All 37 manufacturers in China registered for Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Record

Regulatory record for Cyclone Bone Marrow Concentration System 120mL
Listed by EmCyte Corporation, United States
FDA product code JQC
Device type Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device class Class 1
Regulation 21 CFR 862.2050
Establishment Specification developer, Manufacturer
510(k) K070666
Record published 2019-01-08
Record revised 2020-07-23 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 15 to 30 °C
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Cyclone Bone Marrow Concentration System 120mL
Catalogue number Size Status
CYC-120-01 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Thermo Scientific Thermo Electron LED GmbH 131
Yingtai Changsha Yingtai Instrument Co., Ltd. 39
Globe Scientific Globe Scientific, LLC 33
Swing-out rotor Andreas Hettich Gmbh 28
LW Scientific, Inc` LW Scientific, Inc. 23
Angle rotor Andreas Hettich Gmbh 21
Bucket Andreas Hettich Gmbh 21
Harvest® SmartPrep® Terumo BCT, Inc.. 12
LW Scientific LW Scientific, Inc. 12
Biobase Biobase Biodustry(Shandong)Co., Ltd. 9
ART BMC System Centrifuge Celling Biosciences 9
Harvest® Terumo BCT, Inc.. 8

Showing 12 of 635. All products under Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K183205 2019-05-30

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