Diagnostix™
Adstation Oto PMV-LED/Coax+Oph-LED, 429, ,9003W/Spec Disp, WB, EU
11manufacturers in China registered for this device type
325catalogue numbers in this listing
1510(k) clearance
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 | American Diagnostic Corp., United States |
|---|---|
| FDA product code | HLJ |
| Device type | Ophthalmoscope, Battery-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1570 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K093495 |
| Record published | 2017-11-30 |
| Record revised | 2020-12-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 0 to 95 % RH; Storage environment temperature -4 to 120.2 °F |
| Packaging | Master case of 4, inner pack of 10, master case of 10, master case of 6 |
| Distribution end date | 2019-05-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5112NBD | In distribution | |
| 5611L-346X9EUW | In distribution | |
| 56802X-39W | In distribution | |
| 5680B-356L | In distribution | |
| 5681L-36LEU | In distribution | |
| 5611L-36X8EUW | In distribution | |
| 56102L-349EUW | In distribution | |
| 5680X-EU | In distribution | |
| 5681X-37EU | In distribution | |
| 5680A-EU | In distribution | |
| 56802X-356X | In distribution | |
| 56802A-6L7EU | In distribution | |
| 5112NSV | In distribution | |
| 5680L-35EU | In distribution | |
| 5681L-346X9W | In distribution | |
| 5680X-3 | In distribution | |
| 5112NSBD | In distribution | |
| 5160NG | In distribution | |
| 5681X-36LEU | In distribution | |
| 5110NLS | In distribution | |
| 5681X-3458EUW | In distribution | |
| 5110NV | In distribution | |
| 5680A-6X | In distribution | |
| 5681X-35W | In distribution | |
| 56802X-347W | In distribution | |
| 56802A-36L7EU | In distribution | |
| 56802X-36XEU | In distribution | |
| 5140NLGR | In distribution | |
| 5681X-356X | In distribution | |
| 5681L-6L | In distribution | |
| 5680B-347W | In distribution | |
| 5680X-6L7EU | In distribution | |
| 56802A-37EU | In distribution | |
| 5680B-38EUW | In distribution | |
| 5610B-349EUW | In distribution | |
| 56802L-348EUW | In distribution | |
| 5611X-36L8EUW | In distribution | |
| 5140NLV | In distribution | |
| 56802X-EU | In distribution | |
| 56802X-35EU | In distribution | |
| 5681L-36XEU | In distribution | |
| 5681X-359EUW | In distribution | |
| 5680B-349W | In distribution | |
| 56802L-39W | In distribution | |
| 5112N-4 | In distribution | |
| 5110EV | In distribution | |
| 5680B-356X | In distribution | |
| 5681L-356L | In distribution | |
| 5112NLG | In distribution | |
| 5110NAC | In distribution | |
| 5110NL | In distribution | |
| 56802B-348EUW | In distribution | |
| 56102A-348EUW | In distribution | |
| 56802X-6L | In distribution | |
| 56802L-356X | In distribution | |
| 5112NLSBD | In distribution | |
| 5680L-3 | In distribution | |
| 5681X-7 | In distribution | |
| 5110NLV | In distribution | |
| 5681X-36L9EUW | In distribution | |
| 56802B-37W | In distribution | |
| 5110NLSBD | In distribution | |
| 56802L-349W | In distribution | |
| 5681L-346L7W | In distribution | |
| 5680B-36LEU | In distribution | |
| 5681X-346X8EUW | In distribution | |
| 5680A-347W | In distribution | |
| 5680L-356X | In distribution | |
| 56802B-6L7EU | In distribution | |
| 5681X-36LW | In distribution | |
| 5680A-3 | In distribution | |
| 5681L-36L9EUW | In distribution | |
| 5681X-6L | In distribution | |
| 5680B-6L7EU | In distribution | |
| 5110NLG | In distribution | |
| 56802A-38EUW | In distribution | |
| 5160NGR | In distribution | |
| 56102B-38W | In distribution | |
| 56802X-37W | In distribution | |
| 56802A-348EUW | In distribution | |
| 4531-1 | In distribution | |
| 56102A-38EUW | In distribution | |
| 5110E | In distribution | |
| 5680X-348EUW | In distribution | |
| 5140NG | In distribution | |
| 5681L-36X8EUW | In distribution | |
| 5680L-6L | In distribution | |
| 5112NSGR | In distribution | |
| 5681X-356L | In distribution | |
| 5681X-346L9W | In distribution | |
| 5680B-3EUW | In distribution | |
| 56802X-3EUW | In distribution | |
| 5112NSG | In distribution | |
| 5112NLRB | In distribution | |
| 5680B-36XEU | In distribution | |
| 56802B-36XEU | In distribution | |
| 5140NLG | In distribution | |
| 56802A-6L | In distribution | |
| 5681L-36X7EUW | In distribution | |
| 5110NBD | In distribution | |
| 5680X-35EU | In distribution | |
| 5110NLSGR | In distribution | |
| 5140N | In distribution | |
| 5680A-349W | In distribution | |
| 5681L-358EUW | In distribution | |
| 5110NS | In distribution | |
| 56802X-6X7EU | In distribution | |
| 5680B-6X | In distribution | |
| 5681X-3 | In distribution | |
| 5611X-36X8EUW | In distribution | |
| 5680X-349W | In distribution | |
| 5611L-3458EUW | In distribution | |
| 5680X-37W | In distribution | |
| 5210-4 | In distribution | |
| 5680B-39W | In distribution | |
| 5681L-36LW | In distribution | |
| 5680B-37W | In distribution | |
| 5611L-346L8EUW | In distribution | |
| 56802A-EU | In distribution | |
| 5680A-38EUW | In distribution | |
| 5110NLGR | In distribution | |
| 56802B-39W | In distribution | |
| 5681L-346L9W | In distribution | |
| 56802X-356L | In distribution | |
| 5610A-38EUW | In distribution | |
| 5680X-38EUW | In distribution | |
| 5680A-3EUW | In distribution | |
| 5140NRB | In distribution | |
| 5140NGR | In distribution | |
| 5611L-346X8EUW | In distribution | |
| 5112NLSRB | In distribution | |
| 5611L-346L9EUW | In distribution | |
| 5681L-6X | In distribution | |
| 5112NLBD | In distribution | |
| 56802A-37W | In distribution | |
| 56802L-6L7EU | In distribution | |
| 5140NV | In distribution | |
| 5680B-6L | In distribution | |
| 5680A-6X7EU | In distribution | |
| 5110NRB | In distribution | |
| 56802A-36X | In distribution | |
| 5680B-3 | In distribution | |
| 5681X-35EU | In distribution | |
| 56802A-6X | In distribution | |
| 5112NLSV | In distribution | |
| 5680L-36XEU | In distribution | |
| 56802B-3EUW | In distribution | |
| 5110NLRB | In distribution | |
| 5681L-359EUW | In distribution | |
| 56802A | In distribution | |
| 56802X-36LEU | In distribution | |
| 5680X-37EU | In distribution | |
| 5681X-36XW | In distribution | |
| 5681X-346X7W | In distribution | |
| 5680X-356L | In distribution | |
| 5680L-6X7EU | In distribution | |
| 56802B-37EU | In distribution | |
| 5610L-38EUW | In distribution | |
| 5112NSRB | In distribution | |
| 5681L-36L8EUW | In distribution | |
| 56802A-39W | In distribution | |
| 5680B-348EUW | In distribution | |
| 5112NL-4 | In distribution | |
| 5681L-37EU | In distribution | |
| 5681L-6L7EU | In distribution | |
| 5110N | In distribution | |
| 5112NV | In distribution | |
| 5681L-36XW | In distribution | |
| 56802A-6X7EU | In distribution | |
| 5680A-36LEU | In distribution | |
| 5611L-36X9W | In distribution | |
| 56102X-38W | In distribution | |
| 5681X-3459W | In distribution | |
| 5110NSGR | In distribution | |
| 5110NGR | In distribution | |
| 5112NLSGR | In distribution | |
| 5681L-35W | In distribution | |
| 56102B-347W | In distribution | |
| 56802B-6X | In distribution | |
| 5110NLSG | In distribution | |
| 5160N | In distribution | |
| 5680L-6L7EU | In distribution | |
| 5110NSBD | In distribution | |
| 5112NGR | In distribution | |
| 5680A-356L | In distribution | |
| 56802A-36X7EU | In distribution | |
| 5610A-348EUW | In distribution | |
| 5110EKIT1 | In distribution | |
| 56102X-349EUW | In distribution | |
| 5110ERB | In distribution | |
| 5610X-38W | In distribution | |
| 5680X-6X7EU | In distribution | |
| 5680X-347W | In distribution | |
| 5680B-6X7EU | In distribution | |
| 5110NLBD | In distribution | |
| 5112NLV | In distribution | |
| 5680A-37W | In distribution | |
| 56802B-EU | In distribution | |
| 56802B-38EUW | In distribution | |
| 5681X-36XEU | In distribution | |
| 5680X-39W | In distribution | |
| 56802L-36LEU | In distribution | |
| 56802L-6X | In distribution | |
| 5681L-3 | In distribution | |
| 5681L-36X7 | In distribution | |
| 5681L-6X7EU | In distribution | |
| 56802L-38EUW | In distribution | |
| 5681L-3458EUW | In distribution | |
| 5680X-36XEU | In distribution | |
| 5610L-349EUW | In distribution | |
| 5112NS | In distribution | |
| 5680L-37W | In distribution | |
| 56802X-3 | In distribution | |
| 56802B-6L | In distribution | |
| 56802B-36LEU | In distribution | |
| 5110NSG | In distribution | |
| 5110EGR | In distribution | |
| 56802L-37W | In distribution | |
| 5680L-6X | In distribution | |
| 5681X-36X8EUW | In distribution | |
| 56802B-347W | In distribution | |
| 5681L-EU | In distribution | |
| 56102A-347W | In distribution | |
| 5681L-346L8EUW | In distribution | |
| 5610X-349EUW | In distribution | |
| 5110EL | In distribution | |
| 5680A-6L7EU | In distribution | |
| 5680L-356L | In distribution | |
| 5680A-37EU | In distribution | |
| 5110EBD | In distribution | |
| 56802X-348EUW | In distribution | |
| 5680X-6L | In distribution | |
| 56102L-348EUW | In distribution | |
| 56802L-36XEU | In distribution | |
| 5680B-EU | In distribution | |
| 5680A-36XEU | In distribution | |
| 5681L-35EU | In distribution | |
| 5112NLGR | In distribution | |
| 56802A-3EUW | In distribution | |
| 56802X-349W | In distribution | |
| 56802L-35EU | In distribution | |
| 5680X-3EUW | In distribution | |
| 5681L-3459W | In distribution | |
| 56802L-347W | In distribution | |
| 5681X-346L8EUW | In distribution | |
| 5681X-346LW | In distribution | |
| 5110NG | In distribution | |
| 56802L-37EU | In distribution | |
| 5681X-3457W | In distribution | |
| 5681X-6X | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Adstation™ | American Diagnostic Corp. | 586 |
| 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 |
| 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 |
|---|---|
| K093495 | 2010-11-19 |
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.