Rollo 60X15X15E/K130/AR600

2 catalogue numbers from 1006017, listed by AB Medica Group S. A., Spain, under Recorder, Paper Chart. 9 manufacturers in China are registered for this product code.

Registry build 21.09.26
9manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code DSF
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Orantech Inc. Shenzhen Guangdong Contract manufacturer 40
Little Doctor Electronic(Nantong) Co., Ltd. Nantong Jiangsu Contract manufacturer 17
Xiamen MK Health Care Product Co., Ltd. Xiamen Fujian Manufacturer 7
Tianjin Grand Paper Industry Co., Ltd. Tianjin Tianjin Manufacturer 2

Record

Regulatory record for Rollo 60X15X15E/K130/AR600
Listed by AB Medica Group S. A., Spain
FDA product code DSF
Device type Recorder, Paper Chart
Device class Class 1
Regulation 21 CFR 870.2810
Establishment Manufacturer
Premarket notification Exempt
Record published 2025-03-26

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, manufacturing date, serial number
Storage Special storage condition: Keep away from sunlight; Handling environment humidity 20 to 80 % RH; Handling environment temperature 0 to 40 °C; Special storage condition: Keep Dry

Catalogue Numbers

Catalogue numbers for Rollo 60X15X15E/K130/AR600
Catalogue number Size Status
1006017 In distribution
1006025 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Vermed Graphic Controls Acquisition Corporation 153
Cardinal Health Cardinal Health 200, LLC 91
Kendall Cardinal Health 54
Henry Schein Henry Schein, Inc. 31
non branded Cardinal Health 28
ECG Recording Paper Diagramma AG 16
Welch Allyn, Inc. Welch Allyn, Inc. 16
MediChoice Owens & Minor Distribution, Inc. 15
Fukuda Denshi Fukuda Denshi Co., Ltd. 13
GE Healthcare Graphic Controls Acquisition Corporation 12
Paper Philips Medical Systems Hsg 12
Curaplex Bound Tree Medical, LLC 5

Showing 12 of 851. All products under Recorder, Paper Chart

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