Embedding Cassette

4 catalogue numbers from C02, listed by Dakewe(Shenzhen) Medical Equipment Co., Ltd., China, under Container, Embedding. 8 manufacturers in China are registered for this product code.

Registry build 21.09.26
8manufacturers in China registered for this device type
4catalogue 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 Embedding Cassette
Listed by Dakewe(Shenzhen) Medical Equipment Co., Ltd., China
FDA product code KER
Device type Container, Embedding
Device class Class 1
Regulation 21 CFR 864.3010
Establishment Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-12-27

Specifications

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

Catalogue Numbers

Catalogue numbers for Embedding Cassette
Catalogue number Size Status
C02 In distribution
C03 In distribution
C00 In distribution
C01 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® Sakura Finetek U.S.A., Inc. 17
Tissue-Tek® Quick-Ray™ Sakura Finetek U.S.A., Inc. 6
Tissue-Tek® NanoMold™ Sakura Finetek U.S.A., Inc. 5
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