Gimmi
Alpha Multistore Acquisition BOX HD Inclusive Software "personal"
8manufacturers in China registered for this device type
9catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Shenzhen Sophway Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Gimmi Gmbh, Germany |
|---|---|
| FDA product code | FET |
| Device type | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K221591 |
| Record published | 2026-03-04 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Hydrogen Peroxide |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CAM.1111.02 | In distribution | |
| CAM.1113.00 | In distribution | |
| S.2046.70 HD | In distribution | |
| CAM.4140.00 | In distribution | |
| CAM.1113.90 | In distribution | |
| CAM.2143.00 | In distribution | |
| S.2046.50 | In distribution | |
| CAM.4143.00 | In distribution | |
| S.2046.60 HD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endocam | Richard Wolf Gmbh | 21 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Karl Storz GmbH & Co. KG | 20 |
| Image 1 | Karl Storz GmbH & Co. KG | 8 |
| Exalt™ | Boston Scientific Corporation | 8 |
| Conmed | ConMed Corporation | 7 |
| Video Adapter | Olympus Medical Systems Corp. | 6 |
| EleVision™ | Schölly Fiberoptic GmbH | 6 |
| Evis Exera Colonovideoscope | Olympus Medical Systems Corp. | 5 |
| Water Resistant CAP | Olympus Medical Systems Corp. | 5 |
| CystoView™ | Verathon Medical (Canada) ULC | 5 |
| Riwo | Richard Wolf Gmbh | 5 |
| Video Processor | Pentax of America, Inc. | 5 |
Showing 12 of 105. All products under Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K012660 | 2001-12-20 |
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.