Epredia

"The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are…

Registry build 21.09.26

“The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.”

6manufacturers in China registered for this device type
30catalogue numbers in this listing

Who Else Makes It

Concentrated in Shandong (2), Shanghai (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code IDL
Manufacturer City Province Registered as Device types
Infitek Co., Ltd. Shanghai Shanghai Manufacturer 49
Diatrust Medical Co., Ltd. Nanjing Jiangsu Manufacturer 48
Labpeak Co., Ltd. Jinan Shandong Manufacturer 43
Scitek Global Co., Ltd. Jinan Shandong Manufacturer 43
Wuhan Landing Intelligence Medical Co., Ltd. Wuhan Hubei Manufacturer 17
Jinhua Craftek Instrument Co., Ltd. Jinhua Zhejiang Manufacturer 2

Record

Regulatory record for Epredia
Listed by Richard-Allan Scientific LLC, United States
FDA product code IDL
Device type Microtome, Accessories
Device class Class 1
Regulation 21 CFR 864.3010
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-10-28

Specifications

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

Catalogue Numbers

Catalogue numbers for Epredia
Catalogue number Size Status
Standard Microtome Knife 125 mm In distribution
Microtome Knife, 12 CM, C In distribution
Adamas Blades for Disposable Magnetic Blade Carriers 60 mm 10/cs In distribution
Microtome Knife C-Profile 240 mm In distribution
Microtome Knife, 16 CM, C In distribution
Microtome Knife, 30CM, C In distribution
Microtome Knife, 12 CM, D In distribution
MB22 Premier Microtome Blade In distribution
Premium High Profile Microtome Blades with PTFE coating In distribution
Edge-Rite™ Low Profile Disposable Microtome Blades In distribution
MB DynaSharp Microtome Blade In distribution
Microtome Knife D-Profile 160 mm In distribution
Microtome Knife D-Profile 240 mm In distribution
MX35 Premier Microtome Blade In distribution
Standard Microtome Knife 250 mm In distribution
Microtome Knife, 16 CM, D In distribution
Stainless-Steel Microtome Knives 18.5 cm In distribution
HP35 Coated Microtome Blade In distribution
HP35N Ultra Microtome Blade In distribution
Edge-Rite™ High Profile Disposable Microtome Blades In distribution
MX35 Premier+Microtome Blade In distribution
Stainless-Steel Microtome Knives 12.5 cm In distribution
Tungsten Carbide Knife, 16 CM In distribution
MX35 Ultra Microtome Blade In distribution
Microtome Knife, 22 CM, D In distribution
Adamas Blades for Disposable Magnetic Blade Carriers 80 mm 10/cs In distribution
Microtome Knife, 30 CM, D In distribution
Premium High Profile Microtome Blades In distribution
Tungsten Carbide D-Profile Microtome Knives In distribution
Microtome Knife, 25 CM, D In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
AccuThrive® AccuTec, Inc. 12
Feather Microtome Blade Feather Safety Razor Co., Ltd. 7
Robbins Instruments Custom Assemblies, Inc. 2
ClaraTape™ Transfer Tape Clarapath, Inc. 1
ClaraCut™ Blades Clarapath, Inc. 1
ClaraBond™ Slide Coater Adhesive Clarapath, Inc. 1
Fisherbrand Fisher Scientific Company L.L.C. 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