Sunmed
Heine Type X-02.88.086 Opthalmoscope 3
11manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Beijing (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Foshan ANY Home Care Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 20 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Zhejiang Honsun Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 6 |
| Taihu Huamei Medical Equipment Co., Ltd. | Anqing | Anhui | Contract manufacturer | 5 |
Record
| Listed by | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | HLJ |
| Device type | Ophthalmoscope, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1570 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K131719 |
| Record published | 2016-10-03 |
| Record revised | 2024-12-31 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: General Warehouse. Do not get wet. |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5-0239-63 | In distribution | |
| 5-0239-61 | In distribution | |
| 9-7005-00 | Withdrawn | |
| 5-0239-86 | Withdrawn | |
| 5-0239-65 | Withdrawn | |
| 5-0239-85 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Adstation™ | American Diagnostic Corp. | 586 |
| Diagnostix™ | American Diagnostic Corp. | 325 |
| zumax | Zumax Medical Co., Ltd. | 34 |
| Heine Beta® 200 Diagnostic Set | Heine Optotechnik Gmbh & Co. KG. | 22 |
| Heine EN 100® Diagnostic Center | Heine Optotechnik Gmbh & Co. KG. | 20 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 17 |
| R&D Batteries, Inc. | R & D Batteries, Inc. | 11 |
| Heine OMEGA®500 | Heine Optotechnik Gmbh & Co. KG. | 10 |
| Heine EN 200® Diagnostic Center | Heine Optotechnik Gmbh & Co. KG. | 5 |
| Heine K180® Ophthalmoscope | Heine Optotechnik Gmbh & Co. KG. | 4 |
| Proscope™ | American Diagnostic Corp. | 4 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 4 |
Showing 12 of 110. All products under Ophthalmoscope, Battery-Powered
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.