Tissue-Tek®

Base Mold for Embedding Rings 38 x 25 x 12 mm

Registry build 21.09.26
8manufacturers in China registered for this device type
17catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Guangdong (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KER
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Jiangsu Huida Medical Instruments Co., Ltd. Yancheng Jiangsu Contract manufacturer 10
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Citotest Labware Manufacturing Co., Ltd. Haimen Jiangsu Repacker / relabeller 46
Citotest Scientific Co., Ltd. Nanjing Jiangsu Repacker / relabeller 46
Dakewe(Shenzhen) Medical Equipment Co., Ltd. Shenzhen Guangdong Repacker / relabeller 9
Yancheng Jingwei Chemicals Co., Ltd. Yancheng Jiangsu Manufacturer 7
Guangzhou Labsim Biotech Co., Ltd. Guangzhou Guangdong Manufacturer 3

Record

Regulatory record for Tissue-Tek®
Listed by Sakura Finetek U.S.A., Inc., United States
FDA product code KER
Device type Container, Embedding
Device class Class 1
Regulation 21 CFR 864.3010
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-12-25

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Tissue-Tek®
Catalogue number Size Status
4133 In distribution
4122 In distribution
4116 In distribution
4164 In distribution
4161 In distribution
4162 In distribution
4123 In distribution
4165 In distribution
4151 In distribution
4114 In distribution
4131 In distribution
4113 In distribution
4115 In distribution
4124 In distribution
4132 In distribution
4121 In distribution
4163 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Epredia Richard-Allan Scientific LLC 18
Tissue-Tek® Quick-Ray™ Sakura Finetek U.S.A., Inc. 6
Tissue-Tek® NanoMold™ Sakura Finetek U.S.A., Inc. 5
Embedding Cassette Dakewe(Shenzhen) Medical Equipment Co., Ltd. 4
Tissue-Tek® Cryomold® Sakura Finetek U.S.A., Inc. 3
Tissue-Tek® Paraform® Sakura Finetek U.S.A., Inc. 3
Cryomold® Sakura Finetek U.S.A., Inc. 2

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