Heine EN 100® Diagnostic Center
Heine EN 100® Diagnostic Center: 20 catalogue numbers listed by Heine Optotechnik Gmbh & Co. KG., Germany, under Ophthalmoscope, Battery-Powered. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
20catalogue numbers in this listing
5510(k) clearances naming this product code
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 | Heine Optotechnik Gmbh & Co. KG., Germany |
|---|---|
| FDA product code | HLJ |
| Device type | Ophthalmoscope, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1570 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2021-05-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TL | In distribution | |
| TL | In distribution | |
| TL | In distribution | |
| 000 | In distribution | |
| 000 | In distribution | |
| 000 | In distribution | |
| TL | In distribution | |
| TL | In distribution | |
| 000 | In distribution | |
| 000 | In distribution | |
| 000 | In distribution | |
| 000 | In distribution | |
| TL | In distribution | |
| TL | In distribution | |
| 000 | In distribution | |
| 000 | In distribution | |
| 000 | In distribution | |
| TL | In distribution | |
| 000 | In distribution | |
| TL | In distribution |
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 |
| 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 |
| Sunmed | SunMed Group Holdings, LLC | 6 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142486 | 2015-05-18 |
| K142837 | 2015-01-29 |
| K131959 | 2014-03-07 |
| K131961 | 2013-12-04 |
| K123587 | 2013-03-22 |
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.