Dermatome

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Jiangsu and Shandong: 6 hold an FDA registration. 2 are contract manufacturers.

Hong Qiangxing (Shen Zhen) Electronics Limited Guangdong, contract manufacturer
Hynaut Health Technology Co., Ltd. Shandong, contract manufacturer
Jiangsu MJD Medical Technology Co., Ltd. Jiangsu
Shenzhen Denco Medical Co., Ltd. Guangdong, contract manufacturer
Shenzhen Rogin Medical Co., Ltd. Guangdong, contract manufacturer
Shenzhen Xiaobaimaijia Networktechnology Co., Ltd. Guangdong

How Is GFD Classified?

Dermatome is FDA product code GFD, Class 1, 21 CFR 878.4820.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 22 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Process design (8), Process control (6) and Mixed-up of materials/components (3).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Amalgatome SD System (2″ & 4″)

Catalogue number SDSYSTEM024, listed by Exsurco Medical, Inc., United States, under Dermatome. 6 manufacturers in China are registered for this product code.

Micrograft Gauze + Cork Plate, 1: 3, 5-Pack

Catalogue number 2.3/5, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Micrograft Gauze + Cork Plate, 1: 6

Catalogue number 2.6/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Meek Set Machine Driven Complete

Catalogue number 3.MD, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

4-Inch ASD Excision Ring Blade

Amalgatome SD Surgical Skin Grafting and Debridement Blade

Micrograft Gauze + Cork Plate, 1: 6, 5-Pack

Catalogue number 2.6/5, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Mucotome

Catalogue number 1970nou, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

Blade for Mucotome

Catalogue number 1975, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

Dermatome 100mm

Catalogue number 1983nou, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

Blade for Dermatome 75mm

Catalogue number 1995, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

Amalgatome SD 4-Inch Cutting Head

Blade Head 4" ASD; Excision ring blade head

Medline Industries, Inc.

Blade Dermatome

Micrograft Gauze + Cork Plate, 1: 4

Catalogue number 2.4/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Acculan 3TI

Acculan 3Ti dermatome

Micrograft Gauze + Cork Plate, 1: 3

Catalogue number 2.3/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Blade for Dermatome 12mm

Catalogue number 1998, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

Humeca D42 Dermatome Blade

Catalogue number 5.D42BL/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Meek Set Hand Driven Complete

Catalogue number 3.HD, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

D42 Dermatome Set

Catalogue number 4.D42STS, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Amalgatome SD 2-Inch Lock Ring

Lock Ring 2" ASD

Inka

WATSON Skin Graft Knife smooth fixed roller bar 30cm -for Left Hand

Micrograft Gauze + Cork Plate, 1: 9

Catalogue number 2.9/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Amalgatome SD Pneumatic Hose

Pneumatic Hose ASD

Humeca D100 Dermatome Blade

Catalogue number 5.D100BL/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Blade for Dermatome 100mm

Catalogue number 1919, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

NOU-Clean Spray

Cleaning spray for Instruments and Motors 500ml

Amalgatome SD Sterilization Tray

Catalogue number X101005, listed by Exsurco Medical, Inc., United States, under Dermatome. 6 manufacturers in China are registered for this product code.

D100 Dermatome Set

Catalogue number 4.D100STS, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Amalgatome SD 2-Inch Cutting Head

Blade Head 2" ASD; Excision ring blade head

Humeca D80 Dermatome Blade

Catalogue number 5.D80BL/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

D80 Dermatome Set

Catalogue number 4.D80STS, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

TissueMill

Skin Morcellation Device

Dermatome 75mm

Catalogue number 1990nou, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

Dermatome 25mm

Catalogue number 1992nou, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

2-Inch ASD Excision Ring Blade

Amalgatome SD Surgical Skin Grafting and Debridement Blade

Humeca Blade for Padgett® Model B, C and S Dermatome

Catalogue number 5.BLPG/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Amalgatome SD Hand Piece (Drive Unit)

Drive Unit ASD

Dermatome 50mm

Catalogue number 1991nou, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

Dermatome DS 25mm

Catalogue number 1994nou, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

Micro-Line

micro-Line Dermatome acc. to Wagner

Blade for Dermatome 25mm

Catalogue number 1997, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

Humeca Blade for Aesculap®/Acculan® Dermatome

Catalogue number 5.BL4245/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Air Dermatome

Dermatome Hose

Blade for Dermatome 50mm

Catalogue number 1996, listed by Nouvag AG, Switzerland, under Dermatome. 6 manufacturers in China are registered for this product code.

Cellutome™

Cellutome Epidermal Harvesting System Control Unit and Vacuum Head

Hayden Medical

Humby (Modified Braithwaite) Dermatome replacement blade, 1 ea.

Micrograft Gauze + Cork Plate, 1: 4, 5-Pack

Catalogue number 2.4/5, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Amalgatome SD 4-Inch Lock Ring

Lock Ring 4" ASD

Tissue Bank Dermatome

Tissue Bank Dermatome 4" Width Plate

Dermatome

Electric Dermatome Power Supply

Epitech

EPITECH 1002 Control Console. Includes power cord.

Surtex

Schink Dermatome / Skin Graft Knife Adjustable From 0.1 to 2.0 mm 31 cm - 12 1/4" Stainless Steel

Micrograft Gauze + Cork Plate, 1: 2

Catalogue number 2.2/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Trophy Skin

Microderm MD Home Microdermabrasion Machine

Humeca Blade for Zimmer® 8801-8821 Dermatome

Catalogue number 5.BLZM/1, listed by Humeca B.V., under Dermatome. 6 manufacturers in China are registered for this product code.

Novo Surgical Inc.

silvers miniature skin graft knife/dermatome, adjustable, thickness of cut 0.1 mm to 2.0 mm, width of cut 40.0 mm max, 7 1/2" (19.1 cm)

Aesculap

Dermatome Spare Blade (43 mm), sterile, package of 10 pieces

KMI IMI Group

Microdermabrasion Machine

De Soutter Medical

PLASTIC STERI-CONTAINER - 1 x GD-113 DERMATOME

Integra® Padgett® Dermatomes

Integra® Padgett® Dermatomes Five inch Manual Dermatome (Drum and Stand Only), 5X8 Inch Size. (12.5 X 20 cm)(Large)

Integra® Padgett®

Integra® Padgett® Dermatomes Three inch Manual Dermatome (Drum & Stand) 3X8 Inch Size. (7.5 X 20 cm)(Small)

MT

38 catalogue numbers from MT-A-180, listed by Jiangsu MJD Medical Technology Co., Ltd., China, under Dermatome. 6 manufacturers in China are registered for this product code.

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