Seiler Medical Division

The 3D Surgical Microscopes are produced and sold by Seiler Instrument & Manufacturing Co., Inc. There are many types of medical procedures that benefit from the high magnification provided…

Registry build 21.09.26

The 3D Surgical Microscopes are produced and sold by Seiler Instrument & Manufacturing Co., Inc. There are many types of medical procedures that benefit from the high magnification provided by a surgical microscope. The microscope offers the user an illuminated and magnified view of the field of interest. Floor, Wall, and Ceiling support structures are available for mounting and positioning the microscope in a comfortable position for the user. The microscope includes a LED light source to illuminate the area within the field of view. A light guide/cable transfers the output from the light source to the optic pod. The light is then projected through the objective lens to the area of interest, providing relatively shadow-free illumination. The light source also provides two DC outputs to provided power to the 3D display and other electronics. The user must wear polarized 3D glasses while viewing the 3D display to view the illuminated and magnified view of the field of interest. Focus, magnification, and brightness controls offer image options to the user.

9manufacturers in China registered for this device type
87catalogue numbers in this listing

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 Seiler Medical Division
Listed by Seiler Instrument AND Manufacturing Company, Incorporated
FDA product code EPT
Device type Microscope, Surgical
Device class Class 1
Regulation 21 CFR 878.4700
Premarket notification Exempt
Record published 2022-12-06

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries expiry date, manufacturing date, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Seiler Medical Division
Catalogue number Size Status
EVO-500SLIM220 In distribution
AA3-ENT5-LED In distribution
AA6-ENT3-LED220 In distribution
AA3-100-LED220 In distribution
AA3-ENT6-LED220 In distribution
EVO-ENT6SLIM220 In distribution
AA6-ENT4-LED220 In distribution
AA6-ENT3-LED In distribution
AA3-500-LED220 In distribution
AA6-300-LED220 In distribution
AA6-500-LED In distribution
IQ-ENT2SLIM220 In distribution
AA6-100-LED In distribution
AA3-ENT1-LED In distribution
3DV-300 In distribution
IQ-ENT6SLIM220 In distribution
AA6-ENT1-LED220 In distribution
AA6-ENT6-LED220 In distribution
AA3-ENT2-LED220 In distribution
AA3-ENT4-LED In distribution
AA3-200-LED In distribution
IQ-600SLIM220 In distribution
IQ-ENT3SLIM In distribution
AA3-ENT6-LED In distribution
EVO-ENT5SLIM In distribution
AA3-100-LED In distribution
AA3-ENT5-LED220 In distribution
AA3-500-LED In distribution
IQ-ENT5SLIM220 In distribution
AA3-300-LED In distribution
AA6-500-LED220 In distribution
IQ-100SLIM220 In distribution
AA3-600-LED In distribution
3DV-400 In distribution
AA6-ENT2-LED In distribution
AA6-ENT4-LED In distribution
EVO-ENT4SLIM In distribution
AA3-600-LED220 In distribution
AA6-ENT5-LED In distribution
EVO-600SLIM220 In distribution
IQ-ENT3SLIM220 In distribution
EVO-ENT2SLIM In distribution
AA6-200-LED In distribution
EVO-ENT6SLIM In distribution
EVO-ENT4SLIM220 In distribution
AA3-300-LED220 In distribution
IQ-400SLIM220 In distribution
IQ-ENT2SLIM In distribution
IQ-500SLIM220 In distribution
AA6-400-LED220 In distribution
AA6-200-LED220 In distribution
IQ-ENT6SLIM In distribution
AA6-ENT2-LED220 In distribution
EVO-ENT3SLIM220 In distribution
AA3-400-LED In distribution
AA6-600-LED220 In distribution
EVO-ENT5SLIM220 In distribution
AA3-ENT3-LED220 In distribution
3DV-200 In distribution
IQ-ENT1SLIM In distribution
AA3-ENT2-LED In distribution
IQ-ENT1SLIM220 In distribution
EVO-100SLIM220 In distribution
EVO-ENT1SLIM220 In distribution
IQ-ENT5SLIM In distribution
EVO-ENT3SLIM In distribution
IQ-ENT4SLIM In distribution
AA6-600-LED In distribution
AA3-200-LED220 In distribution
AA3-ENT3-LED In distribution
IQ-200SLIM220 In distribution
IQ-ENT4SLIM220 In distribution
AA6-ENT1-LED In distribution
AA3-400-LED220 In distribution
EVO-300SLIM220 In distribution
EVO-ENT2SLIM220 In distribution
EVO-400SLIM220 In distribution
AA3-ENT1-LED220 In distribution
EVO-ENT1SLIM In distribution
AA6-100-LED220 In distribution
AA6-300-LED In distribution
EVO-200SLIM220 In distribution
AA6-ENT5-LED220 In distribution
AA6-400-LED In distribution
AA3-ENT4-LED220 In distribution
AA6-ENT6-LED In distribution
IQ-300SLIM220 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Jedmed Jedmed Instrument Company 144
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
Optomic Optomic España SA 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