Microscope
58 catalogue numbers from RX1, listed by Ecleris SRL, Argentina, under Microscope, Surgical. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
58catalogue 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 | Ecleris SRL, Argentina |
|---|---|
| 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 | 2022-08-10 |
| Record revised | 2024-07-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -30 to 50 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RX1 | In distribution | |
| R01 | In distribution | |
| RX1 | In distribution | |
| RX1 | In distribution | |
| R01 | In distribution | |
| R00 | In distribution | |
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| RX1 | In distribution | |
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| RX1 | In distribution | |
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| R00 | In distribution | |
| RX1 | In distribution | |
| RX1 | In distribution | |
| RX1 | In distribution | |
| R01 | In distribution | |
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| R02 | In distribution | |
| R01 | In distribution | |
| R00 | In distribution | |
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| R02 | In distribution | |
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| RX1 | In distribution | |
| RX1 | In distribution | |
| RX1 | In distribution | |
| R00 | In distribution | |
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| RX1 | In distribution | |
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| RX1 | In distribution | |
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| RX1 | In distribution | |
| R01 | In distribution | |
| RX1 | In distribution | |
| R00 | In distribution | |
| RX1 | In distribution | |
| R00 | In distribution | |
| R00 | In distribution | |
| R01 | In distribution | |
| R00 | In distribution | |
| R02 | In distribution | |
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Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jedmed | Jedmed Instrument Company | 144 |
| Seiler Medical Division | Seiler Instrument AND Manufacturing Company, Incorporated | 87 |
| 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.