Zumax
42 catalogue numbers from HL8000, listed by Zumax Medical Co., Ltd., China, under Light, Surgical Headlight. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
42catalogue numbers in this listing
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 | Zumax Medical Co., Ltd., China |
|---|---|
| FDA product code | EBA |
| Device type | Light, Surgical Headlight |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4630 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-05-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HL8000 | In distribution | |
| HL8350 | In distribution | |
| HL8260 | In distribution | |
| HL8200 | In distribution | |
| HL8300 | In distribution | |
| HL8200 | In distribution | |
| HL8200 | In distribution | |
| HL8260 | In distribution | |
| HL8000 | In distribution | |
| HL8000 | In distribution | |
| HL8000 | In distribution | |
| HL8300 | In distribution | |
| HL8200 | In distribution | |
| HL8000 | In distribution | |
| HL8000 | In distribution | |
| HL8200 | In distribution | |
| HL8260 | In distribution | |
| HL8260 | In distribution | |
| HL8200 | In distribution | |
| HL8200 | In distribution | |
| HL8200 | In distribution | |
| HL8200 | In distribution | |
| HL8350 | In distribution | |
| HL8200 | In distribution | |
| HL8200 | In distribution | |
| HL8300 | In distribution | |
| HL8200 | In distribution | |
| HL8200 | In distribution | |
| HL8350 | In distribution | |
| HL8200 | In distribution | |
| HL8200 | In distribution | |
| HL8300 | In distribution | |
| HL8300 | In distribution | |
| HL8350 | In distribution | |
| HL8300 | In distribution | |
| HL8000 | In distribution | |
| HL8200 | In distribution | |
| HL8350 | In distribution | |
| HL8000 | In distribution | |
| HL8350 | In distribution | |
| HL8000 | In distribution | |
| HL8000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spark™ TruColor™ | Metrex Research | 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 |
| Black & Black Surgical | Black & Black Surgical, Inc. | 6 |
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.