Endo CSV
Endo CSV LED Light
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Unisource Shanghai Ltd. | Shanghai | Shanghai | Reprocessor | 23 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Taizhou Huangyan Guanhong Plastic Steel Products Factory | Taizhou | Zhejiang | Contract manufacturer | 16 |
| Qibei Technology Co., Limited | Kl | Hong Kong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Chamfond Biotech Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Essential Dental Systems, Inc., United States |
|---|---|
| FDA product code | EBA |
| Device type | Light, Surgical Headlight |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4630 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5100-LED | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spark™ TruColor™ | Metrex Research | 42 |
| zumax | Zumax Medical Co., Ltd. | 42 |
| Light, Surgical Headlight | Black & Black Surgical, Inc. | 40 |
| Endeavour™ TruColor™ XL | Metrex Research | 28 |
| Endeavour™ TruColor™ | Metrex Research | 28 |
| Endeavour™ MD | Metrex Research | 22 |
| Orascoptic – Endeavour XL Headlight System | Metrex Research | 18 |
| Orascoptic – Endeavour TruColor Headlight System | Metrex Research | 18 |
| Orascoptic – Endeavour TruColor XL Headlight System | Metrex Research | 18 |
| Orascoptic – Endeavour Headlight System | Metrex Research | 18 |
| Orascoptic – Spark TruColor Headlight System | Metrex Research | 10 |
| Orascoptic – Spark Headlight System | Metrex Research | 10 |
Showing 12 of 24. All products under Light, Surgical Headlight
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.