Epitech

EPITECH 1002 Control Console. Includes power cord.

Registry build 21.09.26
6manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (4), Shandong (1), Jiangsu (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 GFD
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Hynaut Health Technology Co., Ltd. Qingdao Shandong Contract manufacturer 68
Hong Qiangxing (Shen Zhen) Electronics Limited Shenzhen Guangdong Contract manufacturer 19
Jiangsu MJD Medical Technology Co., Ltd. Taizhou Jiangsu Manufacturer 4
Shenzhen Xiaobaimaijia Networktechnology Co., Ltd. Shen Zhen Guangdong Manufacturer 1

Record

Regulatory record for Epitech
Listed by Tara Medical Devices LLC, United States
FDA product code GFD
Device type Dermatome
Device class Class 1
Regulation 21 CFR 878.4820
Establishment Manufacturer
Premarket notification Exempt
Record published 2021-03-04
Record revised 2021-06-22 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Liquid Chemical
Single use Yes
Label carries lot or batch number, manufacturing date, serial number
Storage Handling environment humidity 20 to 80 % RH; Handling environment temperature 16 to 32 °C; Storage environment humidity 10 to 80 % RH; Storage environment temperature 0 to 40 °C

Catalogue Numbers

Catalogue numbers for Epitech
Catalogue number Size Status
1002 In distribution
1002 In distribution
1002 In distribution
1002 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Integra® Padgett® Dermatomes Integra Lifesciences Corporation 62
MT Jiangsu MJD Medical Technology Co., Ltd. 38
Dermatome Zimmer Orthopaedic Surgical Products 30
Integra® Padgett® Integra Lifesciences Corporation 12
Surtex Surtex Instruments Ltd 8
De Soutter Medical DE Soutter Medical Ltd. 7
Aesculap Aesculap AG 7
Cellutome™ KCI USA, Inc. 6
Novo Surgical Inc. Novo Surgical, Inc. 4
Tissue Bank Dermatome Zimmer Orthopaedic Surgical Products 4
Inka The Trustee for Kaiser Family Trust 4
Trophy Skin Trophy Skin, Inc. 3

Showing 12 of 61. All products under Dermatome

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