Maintenance Kit
O-Ring Maintenance Kit, EU, Isolite Isodry
23manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (8), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
Showing 12 of 23. All 23 manufacturers in China registered for Unit, Suction Operatory
Record
| Listed by | Zyris, Inc., United States |
|---|---|
| FDA product code | EBR |
| Device type | Unit, Suction Operatory |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-08 |
| Record revised | 2024-04-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AIL0223 | In distribution | |
| AIL0226 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ACE | Ace Surgical Supply Co., Inc. | 33 |
| Isolite, i3 | Zyris, Inc. | 24 |
| A-dec | A-dec, Inc. | 12 |
| Isovac, Connector | Zyris, Inc. | 9 |
| Aesculap | Aesculap AG | 8 |
| Isodry | Zyris, Inc. | 7 |
| Hygitech | Hygitech | 7 |
| Isovac | Zyris, Inc. | 6 |
| Kohdent | Kohler Medizintechnik GmbH | 5 |
| Isolite, i2 | Zyris, Inc. | 3 |
| Maquira | Maquira Industria de Produtos Odontologicos S/A | 3 |
| Accessories | Zyris, Inc. | 3 |
Showing 12 of 37. All products under Unit, Suction Operatory
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.