Diagnostix™
Diagnostix Portable Set, 3.5v USB, PMV OtoL/Coax+ OphL, Soft,
43manufacturers in China registered for this device type
366catalogue 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 | 2023-07-18 (version 4) |
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 temperature 14 to 131 °F; Storage environment humidity 10 to 95 % RH |
| Packaging | Master case of 3, master case of 4, master case of 10, inner pack of 10, master case, master case of 5 |
| Distribution end date | 2019-05-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5411X | In distribution | |
| 56802L-56X | In distribution | |
| 543802LS | Finger Thickness.31 to.79 inches. | In distribution |
| 54802BS-EU | In distribution | |
| 5580B | In distribution | |
| 5510B-EU | In distribution | |
| 543102XS | Finger Thickness.31 to.79 inches. | In distribution |
| 5120NGR | In distribution | |
| 56802B-56L | In distribution | |
| 55802L-EU | In distribution | |
| 5680L-36L7EU | In distribution | |
| 5680B-36X | In distribution | |
| 54802X | In distribution | |
| 56802A-36LEU | In distribution | |
| 55802A-EU | In distribution | |
| 5680X-6LEU | In distribution | |
| 56802X-5EU | In distribution | |
| 5111NLSV | In distribution | |
| 54316X | Finger Thickness.31 to.79 inches. | In distribution |
| 543802B | Finger Thickness.31 to.79 inches. | In distribution |
| 5681X | In distribution | |
| 5680X-56L | In distribution | |
| 4516-1 | In distribution | |
| 56802A-3EU | In distribution | |
| 5680L-36X | In distribution | |
| 56802A-35EU | In distribution | |
| 5681X-6LEU | In distribution | |
| 56802B-56X | In distribution | |
| 56802L-6XEU | In distribution | |
| 5680A-3W | In distribution | |
| 5410X | In distribution | |
| 5111NSRB | In distribution | |
| 55102X-EU | In distribution | |
| 5120NG | In distribution | |
| 5481L | In distribution | |
| 543802L | Finger Thickness.31 to.79 inches. | In distribution |
| 5680B | In distribution | |
| 5111NSG | In distribution | |
| 5111N-4 | In distribution | |
| 5580L-EU | In distribution | |
| 543122X | Finger Thickness.31 to.79 inches. | In distribution |
| 54122X | In distribution | |
| 54102A | In distribution | |
| 55102L | In distribution | |
| 5111NBD | In distribution | |
| 5411L | In distribution | |
| 54310B | Finger Thickness.31 to.79 inches. | In distribution |
| 55802B-EU | In distribution | |
| 56802A-5EU | In distribution | |
| 54802LS | In distribution | |
| 5680A-6LEU | In distribution | |
| 56802X-56X | In distribution | |
| 5611L-36LEUW | In distribution | |
| 5510X-EU | In distribution | |
| 5680L-7EU | In distribution | |
| 5680A-36L7EU | In distribution | |
| 5680A-5EU | In distribution | |
| 56802X-36L7EU | In distribution | |
| 5510X | In distribution | |
| 54311L | Finger Thickness.31 to.79 inches. | In distribution |
| 5480BS | In distribution | |
| 5111NSBD | In distribution | |
| 5580A-EU | In distribution | |
| 5422X | In distribution | |
| 56802A-7EU | In distribution | |
| 5121N | In distribution | |
| 5580B-EU | In distribution | |
| 5681X-36L | In distribution | |
| 5680X-6XEU | In distribution | |
| 5681L | In distribution | |
| 5510L | In distribution | |
| 543102LS | Finger Thickness.31 to.79 inches. | In distribution |
| 5681X-36X | In distribution | |
| 5111NLBD | In distribution | |
| 54802LS-EU | In distribution | |
| 5111NSV | In distribution | |
| 5680X-36X7EU | In distribution | |
| 54802A | In distribution | |
| 5122N | In distribution | |
| 56802L-36L | In distribution | |
| 5480L-EU | In distribution | |
| 54802B-EU | In distribution | |
| 54312L | Finger Thickness.31 to.79 inches. | In distribution |
| 5680A-7EU | In distribution | |
| 56802X-3W | In distribution | |
| 543802X | Finger Thickness.31 to.79 inches. | In distribution |
| 5411L-EU | In distribution | |
| 5680L-6LEU | In distribution | |
| 5480X-EU | In distribution | |
| 5681L-3EU | In distribution | |
| 54310L | Finger Thickness.31 to.79 inches. | In distribution |
| 5510B | In distribution | |
| 4502-1 | In distribution | |
| 56802B-36L7EU | In distribution | |
| 5680L-36L | In distribution | |
| 54102A-EU | In distribution | |
| 55802A | In distribution | |
| 56802L-3EU | In distribution | |
| 5480LS-EU | In distribution | |
| 5680B-3EU | In distribution | |
| 5680B-36L | In distribution | |
| 54802L | In distribution | |
| 5480B | In distribution | |
| 5111NGR | In distribution | |
| 56802X-36X | In distribution | |
| 54802B | In distribution | |
| 56802A-56X | In distribution | |
| 5681X-36LEUW | In distribution | |
| 5580L | In distribution | |
| 54380AS | Finger Thickness.31 to.79 inches. | In distribution |
| 5681X-5EU | In distribution | |
| 5410B-EU | In distribution | |
| 5611X-3457W | In distribution | |
| 5120NLGR | In distribution | |
| 56802X-36L | In distribution | |
| 56802B | In distribution | |
| 543802XS | Finger Thickness.31 to.79 inches. | In distribution |
| 56802A-3 | In distribution | |
| 5681L-36L7EU | In distribution | |
| 5680B-39EUW | In distribution | |
| 54102B-EU | In distribution | |
| 5681X-36XEUW | In distribution | |
| 5611L-359EUW | In distribution | |
| 5111NS | In distribution | |
| 56802B-356LEU | In distribution | |
| 5681X-36L9W | In distribution | |
| 5681L-56L | In distribution | |
| 5680B-3W | In distribution | |
| 56802L-3W | In distribution | |
| 5580X-EU | In distribution | |
| 5680L-39EUW | In distribution | |
| 54102X-EU | In distribution | |
| 5680X | In distribution | |
| 56802L-5EU | In distribution | |
| 5480AS | In distribution | |
| 54310XS | Finger Thickness.31 to.79 inches. | In distribution |
| 54102L | In distribution | |
| 4514-1 | In distribution | |
| 56802B-357EU | In distribution | |
| 54802XS-EU | In distribution | |
| 543122L | Finger Thickness.31 to.79 inches. | In distribution |
| 56802B-39EUW | In distribution | |
| 5681L-36X9W | In distribution | |
| 55102X | In distribution | |
| 5442X | In distribution | |
| 5611X-346X9W | In distribution | |
| 5111NLSRB | In distribution | |
| 5611X-346L7W | In distribution | |
| 5412L-EU | In distribution | |
| 56802X-3EU | In distribution | |
| 5611L-35EUW | In distribution | |
| 5120NLG | In distribution | |
| 5680X-36X | In distribution | |
| 56802L-36X7EU | In distribution | |
| 5510A | In distribution | |
| 56802X-7EU | In distribution | |
| 5440L | In distribution | |
| 54312X | Finger Thickness.31 to.79 inches. | In distribution |
| 56802A-347W | In distribution | |
| 56802B-7EU | In distribution | |
| 54310X | Finger Thickness.31 to.79 inches. | In distribution |
| 5681L-6XEU | In distribution | |
| 56802A-3W | In distribution | |
| 5120NLBD | In distribution | |
| 54102X | In distribution | |
| 5120NLRB | In distribution | |
| 5680B-36X7EU | In distribution | |
| 54381L | Finger Thickness.31 to.79 inches. | In distribution |
| 56802X-36X7EU | In distribution | |
| 5680L | In distribution | |
| 5111NLSG | In distribution | |
| 5480B-EU | In distribution | |
| 5681X-56X | In distribution | |
| 4501-1 | In distribution | |
| 54380XS | Finger Thickness.31 to.79 inches. | In distribution |
| 5480X | In distribution | |
| 56802X-6XEU | In distribution | |
| 56802B-36L | In distribution | |
| 5480AS-EU | In distribution | |
| 54380X | Finger Thickness.31 to.79 inches. | In distribution |
| 54380BS | Finger Thickness.31 to.79 inches. | In distribution |
| 5681X-36X7W | In distribution | |
| 56802A-6XEU | In distribution | |
| 55102B-EU | In distribution | |
| 5681L-56X | In distribution | |
| 56802A-356L | In distribution | |
| 5680B-6LEU | In distribution | |
| 54380A | Finger Thickness.31 to.79 inches. | In distribution |
| 56802A-356X | In distribution | |
| 56802L-36L7EU | In distribution | |
| 543102L | Finger Thickness.31 to.79 inches. | In distribution |
| 5681L-7EU | In distribution | |
| 5680X-3W | In distribution | |
| 5463USBCBL | Finger Thickness.31 to.79 inches. | In distribution |
| 543102B | Finger Thickness.31 to.79 inches. | In distribution |
| 5680A-36X | In distribution | |
| 5680A-39EUW | In distribution | |
| 5410B | In distribution | |
| 5410A-EU | In distribution | |
| 56802A-39EUW | In distribution | |
| 5510A-EU | In distribution | |
| 5481X-EU | In distribution | |
| 54122L-EU | In distribution | |
| 5681X-36X9W | In distribution | |
| 5611L-36L9EUW | In distribution | |
| 5681X-36X7EU | In distribution | |
| 5111NLRB | In distribution | |
| 5681L-36LEUW | In distribution | |
| 5680B-6XEU | In distribution | |
| 5480BS-EU | In distribution | |
| 5111NLSGR | In distribution | |
| 54380B | Finger Thickness.31 to.79 inches. | In distribution |
| 5681X-36L7EU | In distribution | |
| 5680L-36X7EU | In distribution | |
| 5611X-346X7W | In distribution | |
| 54380LS | Finger Thickness.31 to.79 inches. | In distribution |
| 5111NLV | In distribution | |
| 5120NV | In distribution | |
| 55102L-EU | In distribution | |
| 5211-L | In distribution | |
| 55802B | In distribution | |
| 5463ADAPT | Finger Thickness.31 to.79 inches. | In distribution |
| 56802L-36X | In distribution | |
| 5681X-7EU | In distribution | |
| 5410L-EU | In distribution | |
| 4504A-1 | In distribution | |
| 5120NRB | In distribution | |
| 5111NLSBD | In distribution | |
| 56802A-56L | In distribution | |
| 5680L-5EU | In distribution | |
| 5680X-39EUW | In distribution | |
| 54802X-EU | In distribution | |
| 5111NLG | In distribution | |
| 5680A-3EU | In distribution | |
| 4513-1 | In distribution | |
| 5463 | Finger Thickness.31 to.79 inches. | In distribution |
| 5120NBD | In distribution | |
| 56802B-3W | In distribution | |
| 5681L-36L | In distribution | |
| 5680B-7EU | In distribution | |
| 5611L-36XEUW | In distribution | |
| 5480XS-EU | In distribution | |
| 5680A | In distribution | |
| 5111NLGR | In distribution | |
| 543102A | Finger Thickness.31 to.79 inches. | In distribution |
| 54380L | Finger Thickness.31 to.79 inches. | In distribution |
| 54802AS | In distribution | |
| 5680A-56L | In distribution | |
| 56802L-6LEU | In distribution | |
| 54802XS | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 247 |
| Prosidio | Prosidio LLC | 38 |
| mytaMed | Mytamed, Inc. | 33 |
| Adstation™ | American Diagnostic Corp. | 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.