Olympus
Catalogue number WA97013A, listed by Olympus Winter & IBE Gmbh, Germany, under Source, Carrier, Fiberoptic Light. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Fanxing Guangdian Medical Treatment Equipment Co Ltd | Beijing | Beijing | Contract manufacturer | 5 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
| Shenzhen Shanglaite Electronic Technology Co., Ltd. | Shenzhen | Guangdong | Remanufacturer | 4 |
Record
| Listed by | Olympus Winter & IBE Gmbh, Germany |
|---|---|
| FDA product code | EQH |
| Device type | Source, Carrier, Fiberoptic Light |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4350 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-06-20 |
| Record revised | 2026-05-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WA97013A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pilling | Teleflex Medical LLC | 216 |
| Jedmed | Jedmed Instrument Company | 80 |
| Millennium | Avalign Technologies, Inc. | 72 |
| Ambler Surgical | Ambler Surgical, LLC | 40 |
| Elmed Incorporated | Elmed, Inc. | 36 |
| Fentex | Fentex medical GmbH | 36 |
| MicroFrance® | Integra Microfrance SAS | 24 |
| Elmed | Elmed, Inc. | 23 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 19 |
| Source, Carrier, Fiberoptic Light | Schölly Fiberoptic GmbH | 17 |
| BR Surgical, LLC | BR Surgical LLC | 16 |
| Bear | Mytamed, Inc. | 12 |
Showing 12 of 50. All products under Source, Carrier, Fiberoptic Light
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.