Jedmed
Mirror W/ Standard Handle 18MM Size 4
94manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (23), Shanghai (15), Jiangsu (14). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| Yangzhou Haiwang Toothbrush Factory | Yangzhou | Jiangsu | Contract manufacturer | 12 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Perfect Group Corp. Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 9 |
| Dongguan Shun King Company Limited | Dongguan | Guangdong | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Showing 12 of 94. All 94 manufacturers in China registered for Mirror, Mouth
Record
| Listed by | Jedmed Instrument Company, United States |
|---|---|
| FDA product code | EAX |
| Device type | Mirror, Mouth |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 48-0008 | In distribution | ||
| 48-0040 | In distribution | ||
| 48-0042 | In distribution | ||
| 48-0054 | In distribution | ||
| 68-0110 | In distribution | ||
| 68-0401 | In distribution | ||
| 48-0020 | In distribution | ||
| 48-0050 | In distribution | ||
| 48-0038 | In distribution | ||
| 48-0046 | In distribution | ||
| 68-0105 | In distribution | ||
| 48-0071 | In distribution | ||
| 48-0080 | In distribution | ||
| 68-0501 | In distribution | ||
| 48-0014 | In distribution | ||
| 48-0052 | In distribution | ||
| 48-0012 | In distribution | ||
| 48-0072 | In distribution | ||
| 48-0024 | In distribution | ||
| 48-0056 | In distribution | ||
| 48-0016 | In distribution | ||
| 48-0048 | In distribution | ||
| 68-0301 | In distribution | ||
| 68-0103 | In distribution | ||
| 68-0501 B | 12 | In distribution | |
| 48-0081 | In distribution | ||
| 48-0044 | In distribution | ||
| 48-0022 | In distribution | ||
| 48-0026 | In distribution | ||
| 48-0010 | In distribution | ||
| 48-0018 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| E. Hahnenkratt GmbH | E. Hahnenkratt Gmbh | 118 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 108 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 86 |
| Crystal HD® Mouth Mirrors | Zirc Dental Products, Inc. | 65 |
| Sklar® | Sklar Corporation | 60 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 59 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 43 |
| Osung MND | Osung MND Co., Ltd. | 39 |
| Mouth Mirror Handle | Zirc Dental Products, Inc. | 33 |
| Plasdent | Plasdent Corp. | 30 |
| Henry Schein | Henry Schein, Inc. | 27 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 26 |
Showing 12 of 205. All products under Mirror, Mouth
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.