StatLab

Cervical Papette Cell Collector

Registry build 21.09.26
8manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (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 GEE
Manufacturer City Province Registered as Device types
Goodwood Medical Care Ltd Dalian Liaoning Contract manufacturer 19
Yancheng Huida Medical Instruments Co., Ltd. Yancheng Jiangsu Contract manufacturer 10
Ningbo Tianbo First AID Product Co., Ltd. Ningbo Zhejiang Repacker / relabeller 66
Dongguan City Ruimi Gift Products Co Ltd Dongguan Guangdong Repacker / relabeller 62
Diatrust Medical Co., Ltd. Nanjing Jiangsu Manufacturer 48
Ningbo Yingmed Medical Instruments Co., Ltd. Ningbo Zhejiang Manufacturer 29
Jiangsu Suyun Medical Materials Co., Ltd. Lianyungang Jiangsu Contract manufacturer 11
Guangzhou Aoqun New Materials Co., Ltd. Guangzhou Guangdong Manufacturer 6

Record

Regulatory record for StatLab
Listed by Yancheng Huida Medical Instruments Co., Ltd., China
FDA product code GEE
Device type Brush, Biopsy, General & Plastic Surgery
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2024-05-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 100, case of 20

Catalogue Numbers

Catalogue numbers for StatLab
Catalogue number Size Status
CB400-100 In distribution
CB500-100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 18
Conmed ConMed Corporation 6
Midas Rex Medtronic Powered Surgical Solutions 6
Single Use Brush Biopsy Instrument Endo-Therapeutics, Inc. 5
gSource Gsource, LLC. 3
Swab-PAK Medical Packaging Corporation 2
Hobbs Nasal Cytology Brush Hobbs Medical, Inc. 2
Brush, Biopsy, General & Plastic Surgery ConMed Corporation 2
Harrell ConMed Corporation 2
Rovers® Orcellex® Brush RT Rovers Medical Devices B.V. 1
Biopsy Brush Endo-Therapeutics, Inc. 1
SBH SBH Surgical 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