M320 TP12

Table Plate TP12 for M320 - for Leica surgical operating microscope system: M320 TP12

Registry build 21.09.26
9manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (2), Guangxi (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EPT
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
Foshan Coxo Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 19
Foshan Cicada Dental Instrument Co., Ltd. Foshan Guangdong Manufacturer 15
Shanghai Fanta Dental Materials Co., Ltd. Shanghai Shanghai Manufacturer 15
Changzhou Sifary Medical Technology Co., Ltd. Changzhou Jiangsu Manufacturer 14
Guilin Kevin Peter Technology Co., Ltd. Guilin Guangxi Manufacturer 13
Alltion (Guangxi) Instrument Co., Ltd. Wuzhou Guangxi Manufacturer 8
Carl Zeiss Meditec (Suzhou) Co., Ltd. Suzhou Jiangsu Manufacturer 4

Record

Regulatory record for M320 TP12
Listed by Leica Microsystems (Schweiz) AG, Switzerland
FDA product code EPT
Device type Microscope, Surgical
Device class Class 1
Regulation 21 CFR 878.4700
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2021-06-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for M320 TP12
Catalogue number Size Status
000000000010448536 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Jedmed Jedmed Instrument Company 144
Seiler Medical Division Seiler Instrument AND Manufacturing Company, Incorporated 87
Microscope Ecleris SRL 58
M320 Optics Carrier Leica Microsystems (Schweiz) AG 11
Microscope, Surgical Karl Storz GmbH & Co. KG 10
BR Surgical, LLC BR Surgical LLC 8
Vitom Karl Storz GmbH & Co. KG 8
Quintus Karl Storz GmbH & Co. KG 7
Extaro 300 Carl Zeiss Meditec (Suzhou) Co., Ltd. 6
G-Series 3-STEP Microscope With 120 Degree Angled Coupler, AND Dental Composite Global Surgical Corp. 5
G-Series 4-STEP Microscope With 120 Degree Angled Counterbalance Coupler, White Global Surgical Corp. 4
Microcast Karl Storz GmbH & Co. KG 4

Showing 12 of 290. All products under Microscope, Surgical

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