Microscope, Surgical
ARTIP CRUISE Adaptor for VITOM EAGLE
9manufacturers in China registered for this device type
10catalogue 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.
| 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
| Listed by | Karl Storz GmbH & Co. KG |
|---|---|
| FDA product code | EPT |
| Device type | Microscope, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Premarket notification | Exempt |
| Record published | 2025-03-28 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide, Ethylene Oxide, Peracetic Acid, High-level Disinfectant |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| UR002 | In distribution | ||
| UR500C | In distribution | ||
| 9530BD | In distribution | ||
| 28272GM | In distribution | ||
| TH001 | 10 | In distribution | |
| UR007 | In distribution | ||
| UR300 | In distribution | ||
| 20925000 | In distribution | ||
| 28272CN | In distribution | ||
| TH004 | In distribution |
Same 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 |
| 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.