Adstation™
Diagnostix Portable Set, 3.5v,OtoX/Oph2X, Soft, Euro
43manufacturers in China registered for this device type
33catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (15), Guangdong (15), Jiangsu (5). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Essentia Industries Ltd. | Dong Guan | Guangdong | Contract manufacturer | 31 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Showing 12 of 43. All 43 manufacturers in China registered for Otoscope
Record
| Listed by | American Diagnostic Corp., United States |
|---|---|
| FDA product code | ERA |
| Device type | Otoscope |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4770 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K932506 |
| Record published | 2016-09-21 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature 14 to 131 °F |
| Packaging | Inner pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54102BS | In distribution | |
| 54102XS | In distribution | |
| 5412-4X | In distribution | |
| 54102LS | In distribution | |
| 5411-4L | In distribution | |
| 5410LS-EU | In distribution | |
| 5500EU | In distribution | |
| 5410AS-EU | In distribution | |
| 5410XS | In distribution | |
| 5410BS | In distribution | |
| 5416L | In distribution | |
| 5420L | In distribution | |
| 5410BS-EU | In distribution | |
| 5416X | In distribution | |
| 5410LS | In distribution | |
| 5416X-EU | In distribution | |
| 5410AS | In distribution | |
| 5410XS-EU | In distribution | |
| 5412-4L | In distribution | |
| 5411-AD | In distribution | |
| 54102XS-EU | In distribution | |
| 54102AS-EU | In distribution | |
| 5426X | In distribution | |
| 5416L-EU | In distribution | |
| 5420X | In distribution | |
| 54102LS-EU | In distribution | |
| 5560BAT | In distribution | |
| 5411-4X | In distribution | |
| 54102AS | In distribution | |
| 5426L | In distribution | |
| 54102BS-EU | In distribution | |
| 5460BAT | In distribution | |
| 5460EU | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diagnostix™ | American Diagnostic Corp. | 366 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 247 |
| Prosidio | Prosidio LLC | 38 |
| mytaMed | Mytamed, Inc. | 33 |
| Jedmed | Jedmed Instrument Company | 32 |
| zumax | Zumax Medical Co., Ltd. | 21 |
| Otoscope | Karl Storz GmbH & Co. KG | 17 |
| Firefly | Firefly Global | 12 |
| Otopront | Happersberger Otopront Gmbh | 11 |
| Bear | Mytamed, Inc. | 10 |
| Otoscope | Ecleris SRL | 9 |
| Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | 8 |
Showing 12 of 247. All products under Otoscope
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.